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"type": "adverse reactions",
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" 6 ADVERSE REACTIONS\n\n EXCERPT: Most commonly reported adverse reactions were flushing (2%), headache (1%), increased blood pressure (2%), nausea (1%), and dizziness (1%).\n\n\n\n To report SUSPECTED ADVERSE REACTIONS, contact GE Healthcare at 1-800-654-0118 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. ( 6 )\n\n\n\n \n\n 6.1 Clinical Trials Experience\n\n Clinical trials are conducted under widely varying conditions and adverse reaction rates observed in the clinical trials of Vizamyl cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.\n\n\n\n In clinical trials, 761 adults (367 men and 394 women, 91% Caucasian) with a mean age of 62 years (range 18-93 years) received Vizamyl. Most subjects (530, 70%) received a dose of 185 MBq (5 mCi).\n\n\n\n One subject out of 761 administered Vizamyl experienced a serious hypersensitivity reaction with flushing, dyspnea and chest pressure within minutes following Vizamyl administration and recovered with treatment.\n\n\n\n Most adverse reactions were mild to moderate in intensity and resolved spontaneously. The most commonly reported adverse reactions (occurring in at least 1% of subjects) in Vizamyl-treated subjects are shown in Table 2.\n\n\n\n Table 2: Adverse Reactions Reported in Clinical Trials of Vizamyl (N = 761 subjects) \n Adverse Reaction N (percent of patients) \n \n Flushing 16 (2%) \n Increased blood pressure 13 (2%) \n Headache 10 (1%) \n Nausea 8 (1%) \n Dizziness 8 (1%) \n"
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" 5 WARNINGS AND PRECAUTIONS\n\n\n\n EXCERPT: * Hypersensitivity reactions: Ask patients about prior reactions to Vizamyl. Observe for hypersensitivity signs and symptoms following Vizamyl administration. Have resuscitation equipment and trained personnel available at time of Vizamyl administration ( 5.1 ) \n * Image interpretation errors (especially false positives) have been observed ( 5.2 ) \n * Radiation risk: Vizamyl, similar to all radiopharmaceuticals, contributes to a patient's long-term cumulative radiation exposure. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure ( 2.1 , 5.3 ) \n \n \n\n 5.1 Hypersensitivity Reactions\n\n\n\n Hypersensitivity reactions such as flushing and dyspnea have been observed within minutes following Vizamyl administration. These reactions may occur in patients with no history of prior exposure to Vizamyl.\n\n\n\n Before administering Vizamyl, ask patients about prior reactions to drugs, especially those containing polysorbate 80.\n\n\n\n Have resuscitation equipment and trained personnel immediately available at the time of Vizamyl administration [ see Contraindications (4) ].\n\n\n\n 5.2 Risk for Image Misinterpretation and Other Errors\n\n\n\n Errors may occur while using Vizamyl PET images to estimate brain neuritic plaque density [ see Clinical Studies (14) ].\n\n\n\n Image interpretation is performed independently of the patient's clinical information. The use of clinical information in the interpretation of Vizamyl images has not been evaluated and may lead to errors. Extensive brain atrophy may limit the ability to distinguish grey and white matter on a Vizamyl scan [ see Dosage and Administration (2.5) ]. Motion artifacts may distort the image [ see Dosage and Administration (2.3) ].\n\n\n\n Vizamyl scan results are indicative of the brain neuritic amyloid plaque content only at the time of image acquisition and a negative scan result does not preclude the development of brain amyloid in the future.\n\n\n\n 5.3 Radiation Risk\n\n\n\n Vizamyl, similar to other radiopharmaceuticals, contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk of cancer. Ensure safe handling to protect patients and health care workers from unintentional radiation exposure [ see Dosage and Administration (2.1) ] . \n"
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1 | horizant | [
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" 6 ADVERSE REACTIONS\n\n The following adverse reactions are described in more detail in the Warnings and Precautions section of the label:\n\n\n\n * Somnolence/sedation and dizziness [see Warnings and Precautions ( 5.2 )] \n * RLS: Most common adverse reactions (>=10% and at least 2 times the rate of placebo) were somnolence/sedation and dizziness. ( 6.1 ) \n * PHN: Most common adverse reactions (>=10% and greater than placebo) were dizziness, somnolence, and headache. ( 6.1 ) \n EXCERPT: To report SUSPECTED ADVERSE REACTIONS, contact XenoPort at 1-877-XENOPRT (1-877-936-6778) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. \n 6.1 Clinical Trials Experience\n\n Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.\n\n\n\n In all controlled and uncontrolled trials across various patient populations, more than 2,300 patients have received HORIZANT orally in daily doses ranging from 600 to 3,600 mg.\n\n\n\n Restless Legs Syndrome: The exposure to HORIZANT in 1,201 patients with RLS included 613 exposed for at least 6 months and 371 exposed for at least 1 year. HORIZANT in the treatment of RLS was studied primarily in placebo-controlled trials (n = 642), and in long-term follow-up studies. The population with RLS ranged from 18 to 82 years of age, with 60% being female and 95% being Caucasian.\n\n\n\n The safety of HORIZANT in doses ranging from 600 to 2,400 mg has been evaluated in 515 patients with RLS in 3 double blind, placebo-controlled, 12 week clinical trials. The 600-mg dose was studied in 2 of the 3 studies. Eleven out of 163 (7%) patients treated with 600 mg of HORIZANT discontinued treatment due to adverse reactions compared with 10 of the 245 (4%) patients who received placebo.\n\n\n\n The most commonly observed adverse reactions (>=5% and at least 2 times the rate of placebo) in these trials for the 600 mg dose of HORIZANT were somnolence/sedation and dizziness (see Table 4 ). Table 4 lists treatment-emergent adverse reactions that occurred in >=2% of patients with RLS treated with HORIZANT and numerically greater than placebo.\n\n\n\n Table 4. Incidence of Adverse Reactions in 12 Week RLS Studies Reported in >=2% of Patients Treated With 600 or 1,200 mg of HORIZANT and Numerically Greater Than Placebo \n Body System/Adverse Reaction Placebo a (N = 245)% HORIZANT600 mg/day b (N = 163)% HORIZANT1,200 mg/day c (N = 269)% \n Nervous system disorders \n Somnolence/sedation 6 20 27 \n Dizziness 4 13 22 \n Headache 11 12 15 \n Gastrointestinal disorders \n Nausea 5 6 7 \n Dry mouth 2 3 4 \n Flatulence <1 3 2 \n General disorders and administration site conditions \n Fatigue 4 6 7 \n Irritability 1 4 4 \n Feeling drunk 0 1 3 \n Feeling abnormal <1 <1 3 \n Peripheral edema 1 <1 3 \n Metabolism and nutritional disorders \n Weight increased 2 2 3 \n Increased appetite <1 2 2 \n Ear and labyrinth disorders \n Vertigo 0 1 3 \n Psychiatric disorders \n Depression <1 <1 3 \n Libido decreased <1 <1 2 \n a Placebo was a treatment arm in each of the 3 double-blind, placebo-controlled, 12-week clinical trials. b The 600-mg dose of HORIZANT was a treatment arm in 2 of the 3 double-blind, placebo-controlled, 12-week clinical trials. c The 1,200-mg dose of HORIZANT was a treatment arm in each of the 3 double-blind, placebo-controlled, 12-week clinical trials.\n \n\n \n\n\n\n Adverse reactions reported in these three 12 week studies in <2% of patients treated with 600 mg of HORIZANT and numerically greater than placebo were balance disorder, blurred vision, disorientation, feeling drunk, lethargy, and vertigo.\n\n\n\n The following adverse reactions were dose-related: somnolence/sedation, dizziness, feeling drunk, libido decreased, depression, headache, peripheral edema, and vertigo.\n\n\n\n Postherpetic Neuralgia: The exposure to HORIZANT in 417 patients with PHN included 207 patients exposed for at least 3 months. Overall, the mean age of patients in the PHN studies ranged from 61 to 64 years of age across dose groups; the majority of patients were male (45% to 61%) and Caucasian (80% to 98%).\n\n\n\n The safety of HORIZANT in doses ranging from 1,200 to 3,600 mg has been evaluated in 417 patients with PHN in 3 clinical studies. The principal efficacy study evaluating the efficacy and safety of HORIZANT in the management of PHN was a 12-week, double-blind, multicenter study comparing 1,200 mg/day, 2,400 mg/day and 3,600 mg/day to placebo. Six out of 107 (6%) patients treated with 1,200 mg of HORIZANT discontinued treatment due to adverse events compared with 12 of the 95 (13%) patients who received placebo.\n\n\n\n The most commonly observed adverse reactions (>=10% and greater than placebo) in this trial for the 1,200 mg dose of HORIZANT were dizziness, somnolence, and headache (see Table 5 ). Table 5 lists treatment-emergent adverse reactions that occurred in >=2% of patients with PHN treated with HORIZANT 1,200 mg/day and numerically greater than placebo.\n\n\n\n Table 5. Incidence of Adverse Reactions (in At Least 2% of Patients Treated With 1,200 mg/day of HORIZANT and Numerically Greater Than the Placebo Rate) Reported in All Patients in the 12-Week PHN Study \n Body System/Adverse Reaction Placebo(N = 95)% HORIZANT1,200 mg/day(N = 107)% HORIZANT2,400 mg/day(N = 82)% HORIZANT3,600 mg/day(N = 87)% \n Nervous System \n Dizziness 15 17 26 30 \n Somnolence 8 10 11 14 \n Headache 9 10 10 7 \n Gastrointestinal disorders \n Nausea 5 8 4 9 \n General disorders and administration site conditions \n Fatigue/Asthenia 1 6 4 10 \n Peripheral edema 0 6 7 6 \n Psychiatric disorders \n Insomnia 2 3 5 7 \n Metabolism and nutritional disorders \n Weight increased 1 3 5 5 \n Eye disorders \n Blurred vision 0 2 5 2 \n The following adverse reactions were also reported as >=2% at 2,400 mg/day and/or 3,600 mg/day and appeared to be dose-related but were <2% at 1,200 mg/day: balance disorder, confusional state, depression, dry mouth, flatulence, increased appetite, irritability, and vertigo. Dizziness, somnolence, fatigue, and insomnia appeared to show a dose relationship.\n \n\n 6.2 Adverse Events Associated With Gabapentin\n\n The following adverse events have been reported in patients receiving gabapentin, either in clinical trials or postmarketing: breast enlargement, gynecomastia, and elevated creatine kinase.\n"
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" 5 WARNINGS AND PRECAUTIONS\n\n\n\n EXCERPT: * Driving impairment: Warn patients not to drive until they have gained sufficient experience with HORIZANT to assess whether it will impair their ability to drive. ( 5.1 ) \n * Somnolence/sedation and dizziness: May impair the patient's ability to operate complex machinery. ( 5.2 ) \n * HORIZANT is not interchangeable with other gabapentin products. ( 5.3 ) \n * Suicidal thoughts or behaviors: HORIZANT is a prodrug of gabapentin, an antiepileptic drug (AED). AEDs increase the risk of suicidal thoughts or behaviors. Monitor for suicidal thoughts or behaviors. ( 5.4 ) \n \n \n\n 5.1 Effects on Driving\n\n\n\n HORIZANT may cause significant driving impairment [see Clinical Studies ( 14.3 )] . The duration of driving impairment after starting therapy with HORIZANT is unknown. Patients taking HORIZANT should not drive until they have gained sufficient experience to assess whether HORIZANT impairs their ability to drive. However, prescribers and patients should be aware that patients' ability to assess their own driving competence, as well as their ability to assess the degree of somnolence caused by HORIZANT, can be imperfect. Whether the impairment is related to somnolence [see Warnings and Precautions ( 5.2 )] or other effects of HORIZANT is unknown.\n\n\n\n 5.2 Somnolence/Sedation and Dizziness\n\n\n\n HORIZANT causes somnolence/sedation and dizziness (see Tables 4 and 5 ). Patients should be advised not to drive a car or operate other complex machinery until they have gained sufficient experience on HORIZANT to assess whether HORIZANT impairs their ability to perform these tasks.\n\n\n\n During the controlled trials in patients with RLS, somnolence/sedation was reported in 20% of patients treated with 600 mg of HORIZANT per day compared with 6% of patients receiving placebo. In those patients treated with HORIZANT who reported somnolence, the somnolence persisted during treatment in about 30%. In the remaining patients, symptoms resolved within 3 to 4 weeks. Dizziness was reported in 13% of patients receiving 600 mg of HORIZANT per day compared with 4% of patients receiving placebo. In those patients treated with HORIZANT who reported dizziness, symptoms persisted during treatment in about 20%. Somnolence/sedation led to withdrawal in 2% of patients receiving 600 mg of HORIZANT per day. Dizziness led to withdrawal in 1% of patients receiving 600 mg of HORIZANT per day. The incidence of these adverse reactions was greater in the patients receiving 1,200 mg per day.\n\n\n\n During the 12-week, controlled study in patients with PHN, somnolence was reported in 10% of patients treated with 1,200 mg of HORIZANT per day compared with 8% of patients receiving placebo. Fatigue/asthenia was reported in 6% of patients treated with 1,200 mg of HORIZANT per day compared with 1% of patients receiving placebo. In those patients treated with 1,200 mg of HORIZANT per day who reported somnolence (10%), the somnolence persisted during treatment in about 27%. In the remaining patients, symptoms resolved within 4 to 5 weeks. Dizziness was reported in 17% of patients receiving 1,200 mg of HORIZANT per day compared with 15% of patients receiving placebo. In those patients treated with 1,200 mg of HORIZANT per day who reported dizziness, symptoms persisted during treatment in about 6%. Somnolence led to withdrawal in <1% of patients receiving 1,200 mg of HORIZANT per day compared with 2% of patients receiving placebo. Dizziness led to withdrawal in 2% of patients receiving 1,200 mg of HORIZANT per day compared with 3% of patients receiving placebo.\n\n\n\n 5.3 Lack of Interchangeability With Gabapentin\n\n\n\n HORIZANT is not interchangeable with other gabapentin products because of differing pharmacokinetic profiles. The same dose of HORIZANT results in different plasma concentrations of gabapentin relative to other gabapentin products. [See Clinical Pharmacology ( 12.3 ).] \n\n\n\n The safety and effectiveness of HORIZANT in patients with epilepsy have not been studied.\n\n\n\n 5.4 Suicidal Behavior and Ideation\n\n\n\n HORIZANT (gabapentin enacarbil) is a prodrug of gabapentin, an antiepileptic drug (AED). AEDs increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication. Because HORIZANT is a prodrug of gabapentin, HORIZANT also increases this risk. Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.\n\n\n\n Pooled analyses of 199 placebo-controlled clinical trials (monotherapy and adjunctive therapy) of 11 different AEDs showed that patients randomized to 1 of the AEDs had approximately twice the risk [adjusted relative risk 1.8, 95% confidence interval (CI): 1.2, 2.7] of suicidal thinking or behavior compared with patients randomized to placebo. In these trials, which had a median treatment duration of 12 weeks, the estimated incidence rate of suicidal behavior or ideation among 27,863 AED-treated patients was 0.43%, compared with 0.24% among 16,029 placebo-treated patients, representing an increase of approximately 1 case of suicidal thinking or behavior for every 530 patients treated. There were 4 suicides in drug-treated patients in the trials and none in placebo-treated patients, but the number is too small to allow any conclusion about drug effect on suicide.\n\n\n\n The increased risk of suicidal thoughts or behavior with AEDs was observed as early as 1 week after starting drug treatment with AEDs and persisted for the duration of treatment assessed. Because most trials included in the analysis did not extend beyond 24 weeks, the risk of suicidal thoughts or behavior beyond 24 weeks could not be assessed.\n\n\n\n The risk of suicidal thoughts or behavior was generally consistent among drugs in the data analyzed. The finding of increased risk with AEDs of varying mechanisms of action and across a range of indications suggests that the risk applies to all AEDs used for any indication. The risk did not vary substantially by age (5 to 100 years) in the clinical trials analyzed. Table 3 shows absolute and relative risk by indication for all evaluated AEDs.\n\n\n\n Table 3. Risk by Indication for Antiepileptic Drugs in the Pooled Analysis \n Indication PlaceboPatients WithEvents Per1,000 Patients Drug PatientsWith Events Per1,000 Patients Relative Risk:Incidence of Eventsin DrugPatients/Incidencein Placebo Patients Risk Difference:Additional DrugPatients WithEvents Per 1,000Patients \n Epilepsy 1.0 3.4 3.5 2.4 \n Psychiatric 5.7 8.5 1.5 2.9 \n Other 1.0 1.8 1.9 0.9 \n Total 2.4 4.3 1.8 1.9 \n The relative risk for suicidal thoughts or behavior was higher in clinical trials for epilepsy than in clinical trials for psychiatric or other conditions, but the absolute risk differences were similar for the epilepsy and psychiatric indications.\n \n\n Anyone considering prescribing HORIZANT must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.\n\n\n\n Patients, their caregivers, and families should be informed that HORIZANT increases the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.\n\n\n\n 5.5 Drug Reaction With Eosinophilia and Systemic Symptoms (DRESS)/Multiorgan Hypersensitivity\n\n\n\n Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), also known as multiorgan hypersensitivity, has been reported in patients taking antiepileptic drugs, including gabapentin. HORIZANT is a prodrug of gabapentin. Some of these events have been fatal or life-threatening. DRESS typically, although not exclusively, presents with fever, rash, and/or lymphadenopathy, in association with other organ system involvement, such as hepatitis, nephritis, hematological abnormalities, myocarditis, or myositis sometimes resembling an acute viral infection. Eosinophilia is often present. Because this disorder is variable in its expression, other organ systems not noted here may be involved.\n\n\n\n It is important to note that early manifestations of hypersensitivity, such as fever or lymphadenopathy, may be present even though rash is not evident. If such signs or symptoms are present, the patient should be evaluated immediately. HORIZANT should be discontinued if an alternative etiology for the signs or symptoms cannot be established.\n\n\n\n 5.6 Discontinuation of HORIZANT\n\n\n\n When discontinuing HORIZANT, patients with RLS receiving 600 mg or less once daily can discontinue the drug without tapering. If the recommended dose is exceeded, the dose should be reduced to 600 mg daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure.\n\n\n\n In patients with PHN receiving HORIZANT twice daily, the dose should be reduced to once daily for 1 week prior to discontinuation to minimize the potential of withdrawal seizure, see Table 2 [see Dosage and Administration ( 2.3 )] .\n\n\n\n 5.7 Tumorigenic Potential\n\n\n\n In an oral carcinogenicity study, gabapentin enacarbil increased the incidence of pancreatic acinar cell adenoma and carcinoma in male and female rats [see Nonclinical Toxicology ( 13.1 )] . The clinical significance of this finding is unknown.\n\n\n\n In clinical studies of gabapentin as adjunctive therapy in epilepsy comprising 2,085 patient-years of exposure in patients >12 years of age, new tumors were reported in 10 patients (2 breast, 3 brain, 2 lung, 1 adrenal, 1 non-Hodgkin's lymphoma, 1 endometrial carcinoma in situ), and preexisting tumors worsened in 11 patients (9 brain, 1 breast, 1 prostate) during or up to 2 years following discontinuation of gabapentin. Without knowledge of the background incidence and recurrence in a similar population not treated with gabapentin, it is impossible to know whether the incidence reported in this cohort is or is not affected by treatment.\n"
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] |
2 | pristiq | [
{
"id": "pristiq_section_S1",
"type": "adverse reactions",
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" 6 ADVERSE REACTIONS\n\n The following adverse reactions are discussed in greater detail in other sections of the label.\n\n\n\n * Hypersensitivity [see Contraindications (4) ] \n * Suicidal Thoughts and Behaviors in Adolescents and Young Adults [see Warnings and Precautions (5.1) ] \n * Serotonin Syndrome [see Warnings and Precautions (5.2) ] \n * Elevated Blood Pressure [see Warnings and Precautions (5.3) ] \n * Abnormal Bleeding [see Warnings and Precautions (5.4) ] \n * Angle Closure Glaucoma [ see Warnings and Precautions (5.5) ] \n * Activation of Mania/Hypomania [see Warnings and Precautions (5.6) ] \n * Discontinuation Syndrome [see Warnings and Precautions (5.7) ] \n * Seizure [see Warnings and Precautions (5.8) ] \n * Hyponatremia [see Warnings and Precautions (5.9) ] \n * Interstitial Lung Disease and Eosinophilic Pneumonia [see Warnings and Precautions (5.10) ] \n EXCERPT: Most common adverse reactions (incidence >=5% and twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders ( 6.1 ).\n \n\n To report SUSPECTED ADVERSE REACTIONS, contact Wyeth Pharmaceuticals Inc., a subsidiary of Pfizer Inc., at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch \n\n\n\n \n\n 6.1 Clinical Studies Experience\n\n Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in clinical practice.\n\n\n\n Patient exposure \n\n\n\n PRISTIQ was evaluated for safety in 8,394 patients diagnosed with major depressive disorder who participated in multiple-dose pre-marketing studies, representing 2,784 patient-years of exposure. Of the total 8,394 patients exposed to at least one dose of PRISTIQ; 2,116 were exposed to PRISTIQ for 6 months, representing 1,658 patient-years of exposure, and 421 were exposed for one year, representing 416 patient-years of exposure.\n\n\n\n Adverse reactions reported as reasons for discontinuation of treatment \n\n\n\n In the pre-marketing pooled 8-week placebo-controlled studies in patients with MDD, 1,834 patients were exposed to PRISTIQ (50 to 400 mg). Of the 1,834 patients, 12% discontinued treatment due to an adverse reaction, compared with 3% of the 1,116 placebo-treated patients. At the recommended dose of 50 mg, the discontinuation rate due to an adverse reaction for PRISTIQ (4.1%) was similar to the rate for placebo (3.8%). For the 100 mg dose of PRISTIQ the discontinuation rate due to an adverse reaction was 8.7%.\n\n\n\n The most common adverse reactions leading to discontinuation in at least 2% and at a rate greater than placebo of the PRISTIQ treated patients in the short-term studies, up to 8 weeks, were: nausea (4%); dizziness, headache and vomiting (2% each). In a longer-term study, up to 9 months, the most common was vomiting (2%).\n\n\n\n Common adverse reactions in placebo-controlled MDD studies \n\n\n\n The most commonly observed adverse reactions in PRISTIQ treated MDD patients in pre-marketing pooled 8-week, placebo-controlled, fixed-dose studies (incidence >= 5% and at least twice the rate of placebo in the 50 or 100 mg dose groups) were: nausea, dizziness, insomnia, hyperhidrosis, constipation, somnolence, decreased appetite, anxiety, and specific male sexual function disorders.\n\n\n\n Table 2 shows the incidence of common adverse reactions that occurred in >= 2% of PRISTIQ treated MDD patients and twice the rate of placebo at any dose in the pre-marketing pooled 8-week, placebo-controlled, fixed dose clinical studies\n\n\n\n Table 2: Common Adverse Reactions (>= 2% in any Fixed-Dose Group and Twice the Rate of Placebo) in Pre-marketing Pooled MDD 8-Week Placebo-Controlled Studies \n Percentage of Patients Reporting Reaction \n PRISTIQ \n System Organ Class Preferred Term Placebo (n=636) 50 mg (n=317) 100 mg (n=424) 200 mg (n=307) 400 mg (n=317) \n \n Cardiac disorders \n Blood pressure increased 1 1 1 2 2 \n Gastrointestinal disorders \n Nausea 10 22 26 36 41 \n Dry mouth 9 11 17 21 25 \n Constipation 4 9 9 10 14 \n Vomiting 3 3 4 6 9 \n General disorders and administration site conditions \n Fatigue 4 7 7 10 11 \n Chills 1 1 <1 3 4 \n Feeling jittery 1 1 2 3 3 \n Metabolism and nutrition disorders \n Decreased appetite 2 5 8 10 10 \n Nervous system disorders \n Dizziness 5 13 10 15 16 \n Somnolence 4 4 9 12 12 \n Tremor 2 2 3 9 9 \n Disturbance in attention <1 <1 1 2 1 \n Psychiatric disorders \n Insomnia 6 9 12 14 15 \n Anxiety 2 3 5 4 4 \n Nervousness 1 <1 1 2 2 \n Abnormal dreams 1 2 3 2 4 \n Renal and urinary disorders \n Urinary hesitation 0 <1 1 2 2 \n Respiratory, thoracic and mediastinal disorders \n Yawning <1 1 1 4 3 \n Skin and subcutaneous tissue disorders \n Hyperhidrosis 4 10 11 18 21 \n Special Senses \n Vision blurred 1 3 4 4 4 \n Mydriasis <1 2 2 6 6 \n Vertigo 1 2 1 5 3 \n Tinnitus 1 2 1 1 2 \n Dysgeusia 1 1 1 1 2 \n Vascular disorders \n Hot flush <1 1 1 2 2 \n Sexual function adverse reactions \n \n\n Table 3 shows the incidence of sexual function adverse reactions that occurred in >= 2% of PRISTIQ treated MDD patients in any fixed-dose group (pre-marketing pooled 8-week, placebo-controlled, fixed -dose, clinical studies).\n\n\n\n Table 3: Sexual Function Adverse Reactions (>= 2% in Men or Women in any PRISTIQ Group) During the On-Therapy Period \n PRISTIQ \n Placebo(n=239) 50 mg(n=108) 100 mg(n=157) 200 mg(n=131) 400 mg(n=154) \n Men only \n Anorgasmia 0 0 3 5 8 \n Libido decreased 1 4 5 6 3 \n Orgasm abnormal 0 0 1 2 3 \n Ejaculation delayed <1 1 5 7 6 \n Erectile dysfunction 1 3 6 8 11 \n Ejaculation disorder 0 0 1 2 5 \n Ejaculation failure 0 1 0 2 2 \n Sexual dysfunction 0 1 0 0 2 \n PRISTIQ \n Placebo(n=397) 50 mg(n=209) 100 mg(n=267) 200 mg(n=176) 400 mg(n=163) \n Women only \n Anorgasmia 0 1 1 0 3 \n Other adverse reactions observed in premarketing and postmarketing clinical studies \n \n\n Other infrequent adverse reactions, not described elsewhere in the label, occurring at an incidence of < 2% in MDD patients treated with PRISTIQ were:\n\n\n\n Cardiac disorders - Tachycardia.\n\n\n\n General disorders and administration site conditions - Asthenia.\n\n\n\n Investigations - Weight increased, liver function test abnormal, blood prolactin increased.\n\n\n\n Musculoskeletal and connective tissue disorders - Musculoskeletal stiffness.\n\n\n\n Nervous system disorders - Syncope, convulsion, dystonia.\n\n\n\n Psychiatric disorders - Depersonalization, bruxism.\n\n\n\n Renal and urinary disorders - Urinary retention.\n\n\n\n Skin and subcutaneous tissue disorders - Rash, alopecia, photosensitivity reaction, angioedema.\n\n\n\n In clinical studies, there were uncommon reports of ischemic cardiac adverse reactions, including myocardial ischemia, myocardial infarction, and coronary occlusion requiring revascularization; these patients had multiple underlying cardiac risk factors. More patients experienced these events during PRISTIQ treatment as compared to placebo.\n\n\n\n Laboratory, ECG and vital sign changes observed in MDD clinical studies \n\n\n\n The following changes were observed in pre-marketing placebo-controlled, short-term MDD studies with PRISTIQ.\n\n\n\n Lipids \n\n\n\n Elevations in fasting serum total cholesterol, LDL (low density lipoproteins) cholesterol, and triglycerides occurred in the controlled studies. Some of these abnormalities were considered potentially clinically significant.\n\n\n\n The percentage of patients who exceeded a predetermined threshold value is shown in Table 4.\n\n\n\n Table 4: Incidence (%) of Patients With Lipid Abnormalities of Potential Clinical Significance* \n PRISTIQ \n Placebo 50 mg 100 mg 200 mg 400 mg \n \n Total Cholesterol*(Increase of >= 50 mg/dl and an absolute value of >= 261 mg/dl) 2 3 4 4 10 \n LDL Cholesterol*(Increase >= 50 mg/dl and an absolute value of >= 190 mg/dl) 0 1 0 1 2 \n Triglycerides, fasting*(Fasting: >= 327 mg/dl) 3 2 1 4 6 \n Proteinuria \n \n\n Proteinuria, greater than or equal to trace, was observed in the pre-marketing fixed-dose controlled studies (see Table 5 ). This proteinuria was not associated with increases in BUN or creatinine and was generally transient.\n\n\n\n Table 5: Incidence (%) of Patients with Proteinuria in the Fixed-dose Clinical Studies \n PRISTIQ \n Placebo 50 mg 100 mg 200 mg 400 mg \n \n Proteinuria 4 6 8 5 7 \n Vital sign changes \n \n\n Table 6 summarizes the changes that were observed in placebo-controlled, short-term, pre-marketing studies with PRISTIQ in patients with MDD (doses 50 to 400 mg).\n\n\n\n Table 6: Mean Changes in Vital Signs at Final on Therapy for All Short-term, Fixed-dose Controlled Studies \n PRISTIQ \n Placebo 50 mg 100 mg 200 mg 400 mg \n \n Blood pressure \n Supine systolic bp (mm Hg) -1.4 1.2 2.0 2.5 2.1 \n Supine diastolic bp (mm Hg) -0.6 0.7 0.8 1.8 2.3 \n Pulse rate \n Supine pulse (bpm) -0.3 1.3 1.3 0.9 4.1 \n Weight (kg) 0.0 -0.4 -0.6 -0.9 -1.1 \n Treatment with PRISTIQ at all doses from 50 mg per day to 400 mg per day in controlled studies was associated with sustained hypertension, defined as treatment-emergent supine diastolic blood pressure (SDBP) >=90 mm Hg and >=10 mm Hg above baseline for 3 consecutive on-therapy visits (see Table 7 ). Analyses of patients in PRISTIQ pre-marketing short-term controlled studies who met criteria for sustained hypertension revealed a consistent increase in the proportion of patients who developed sustained hypertension. This was seen at all doses with a suggestion of a higher rate at 400 mg per day.\n \n\n Table 7: Proportion of Patients with Sustained Elevation of Supine Diastolic Blood Pressure \n Treatment Group Proportion of Patients with Sustained Hypertension \n \n Placebo 0.5% \n PRISTIQ 50 mg per day 1.3% \n PRISTIQ 100 mg per day 0.7% \n PRISTIQ 200 mg per day 1.1% \n PRISTIQ 400 mg per day 2.3% \n Orthostatic hypotension \n \n\n In the pre-marketing short-term, placebo-controlled clinical studies with doses of 50 to 400 mg, systolic orthostatic hypotension (decrease >=30 mm Hg from supine to standing position) occurred more frequently in patients >=65 years of age receiving PRISTIQ (8%, 7/87) versus placebo (2.5%, 1/40), compared to patients <65 years of age receiving PRISTIQ (0.9%, 18/1,937) versus placebo (0.7%, 8/1,218).\n\n\n\n 6.2 Postmarketing Experience\n\n The following adverse reaction has been identified during post-approval use of PRISTIQ. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure:\n\n\n\n Skin and subcutaneous tissue disorders - Stevens-Johnson syndrome.\n"
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"\n\n BOXED WARNING: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS\n\n WARNING: SUICIDAL THOUGHTS AND BEHAVIORS \n\n Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies. These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [ see Warnings and Precautions (5.1) ]. \n\n\n\n In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions (5.1) ]. \n\n\n\n PRISTIQ is not approved for use in pediatric patients [ see Use in Specific Populations (8.4) ]. \n\n\n\n EXCERPT: WARNING: SUICIDAL THOUGHTS AND BEHAVIORS\n\n\n\n See full prescribing information for complete boxed warning. \n\n\n\n * Increased risk of suicidal thinking and behavior in children, adolescents and young adults taking antidepressants (5.1). \n * Monitor for worsening and emergence of suicidal thoughts and behaviors (5.1). \n * PRISTIQ is not approved for use in pediatric patients (8.4). \n"
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" 5 WARNINGS AND PRECAUTIONS\n\n\n\n EXCERPT: * Clinical Worsening/Suicide Risk: Monitor for clinical worsening and suicide risk ( 5.1 ). \n * Serotonin Syndrome: Serotonin syndrome has been reported with SSRIs and SNRIs, including with PRISTIQ, both when taken alone, but especially when co-administered with other serotonergic agents (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort). If such symptoms occur, discontinue PRISTIQ and initiate supportive treatment. If concomitant use of PRISTIQ with other serotonergic drugs is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases ( 5.2 ). \n * Elevated Blood Pressure: Control hypertension before initiating treatment. Monitor blood pressure regularly during treatment ( 5.3 ). \n * Abnormal Bleeding: PRISTIQ may increase risk of bleeding events. Caution patients about risk of bleeding associated with concomitant use of PRISTIQ and NSAIDs, aspirin, or other drugs that affect coagulation ( 5.4 ). \n * Angle Closure Glaucoma: Angle closure glaucoma has occurred in patients with untreated anatomically narrow angles treated with antidepressants. ( 5.5 ) \n * Activation of Mania/Hypomania: Use cautiously in patients with Bipolar Disorder. Caution patients about risk of activation of mania/hypomania ( 5.6 ). \n * Discontinuation Syndrome: Taper dose when possible and monitor for discontinuation symptoms ( 5.7 ). \n * Seizure: Can occur. Use cautiously in patients with seizure disorder ( 5.8 ). \n * Hyponatremia: Can occur in association with SIADH ( 5.9 ). \n * Interstitial Lung Disease and Eosinophilic Pneumonia: Can occur ( 5.10 ). \n \n \n\n 5.1 Suicidal Thoughts and Behaviors in Children, Adolescents and Young Adults\n\n\n\n Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled studies of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (ages 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age 24; there was a reduction with antidepressants compared to placebo in adults aged 65 and older.\n\n\n\n The pooled analyses of placebo-controlled studies in children and adolescents with MDD, obsessive compulsive disorder (OCD), or other psychiatric disorders included a total of 24 short-term studies of 9 antidepressant drugs in over 4,400 patients. The pooled analyses of placebo-controlled studies in adults with MDD or other psychiatric disorders included a total of 295 short-term studies (median duration of 2 months) of 11 antidepressant drugs in over 77,000 patients. There was considerable variation in risk of suicidality among drugs, but a tendency toward an increase in the younger patients for almost all drugs studied. There were differences in absolute risk of suicidality across the different indications, with the highest incidence in MDD. The risk differences (drug vs. placebo), however, were relatively stable within age strata and across indications. These risk differences (drug-placebo difference in the number of cases of suicidality per 1,000 patients treated) are provided in Table 1.\n\n\n\n Table 1 \n Age Range Drug-Placebo Difference in Number of Cases of Suicidality per 1,000 Patients Treated \n \n Increases Compared to Placebo \n <18 14 additional cases \n 18 to 24 5 additional cases \n Decreases Compared to Placebo \n 25 to 64 1 fewer case \n >=65 6 fewer cases \n No suicides occurred in any of the pediatric studies. There were suicides in the adult studies, but the number was not sufficient to reach any conclusion about drug effect on suicide.\n \n\n It is unknown whether the suicidality risk extends to longer-term use, i.e., beyond several months. However, there is substantial evidence from placebo-controlled maintenance studies in adults with depression that the use of antidepressants can delay the recurrence of depression.\n\n\n\n All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy, or at times of dose changes, either increases or decreases. \n\n\n\n The following symptoms, anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, and mania, have been reported in adult and pediatric patients being treated with antidepressants for major depressive disorder as well as for other indications, both psychiatric and nonpsychiatric. Although a causal link between the emergence of such symptoms and either the worsening of depression and/or the emergence of suicidal impulses has not been established, there is concern that such symptoms may represent precursors to emerging suicidality.\n\n\n\n Consideration should be given to changing the therapeutic regimen, including possibly discontinuing the medication, in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms that might be precursors to worsening depression or suicidality, especially if these symptoms are severe, abrupt in onset, or were not part of the patient's presenting symptoms.\n\n\n\n If the decision has been made to discontinue treatment, medication should be tapered, as rapidly as is feasible, but with recognition that abrupt discontinuation can be associated with certain symptoms [see Dosage and Administration (2.4) and Warnings and Precautions (5.7) for a description of the risks of discontinuation of PRISTIQ] .\n\n\n\n Families and caregivers of patients being treated with antidepressants for major depressive disorder or other indications, both psychiatric and nonpsychiatric, should be alerted about the need to monitor patients for the emergence of agitation, irritability, unusual changes in behavior, and the other symptoms described above, as well as the emergence of suicidality, and to report such symptoms immediately to healthcare providers. Such monitoring should include daily observation by families and caregivers .\n\n\n\n Prescriptions for PRISTIQ should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.\n\n\n\n Screening patients for bipolar disorder \n\n\n\n A major depressive episode may be the initial presentation of bipolar disorder. It is generally believed (though not established in controlled studies) that treating such an episode with an antidepressant alone may increase the likelihood of precipitation of a mixed/manic episode in patients at risk for bipolar disorder. Whether any of the symptoms described above represent such a conversion is unknown. However, prior to initiating treatment with an antidepressant, patients with depressive symptoms should be adequately screened to determine if they are at risk for bipolar disorder; such screening should include a detailed psychiatric history, including a family history of suicide, bipolar disorder, and depression. It should be noted that PRISTIQ is not approved for use in treating bipolar depression.\n\n\n\n 5.2 Serotonin Syndrome\n\n\n\n The development of a potentially life-threatening serotonin syndrome has been reported with SNRIs and SSRIs, including PRISTIQ, alone but particularly with concomitant use of other serotonergic drugs (including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, tryptophan, buspirone, and St. John's Wort), and with drugs that impair metabolism of serotonin (in particular, MAOIs, both those intended to treat psychiatric disorders and also others, such as linezolid and intravenous methylene blue).\n\n\n\n Serotonin syndrome symptoms may include mental status changes (e.g., agitation, hallucinations, delirium, and coma), autonomic instability (e.g., tachycardia, labile blood pressure, dizziness, diaphoresis, flushing, hyperthermia), neuromuscular symptoms (e.g., tremor, rigidity, myoclonus, hyperreflexia, incoordination), seizures, and/or gastrointestinal symptoms (e.g., nausea, vomiting, diarrhea). Patients should be monitored for the emergence of serotonin syndrome.\n\n\n\n The concomitant use of PRISTIQ with MAOIs intended to treat psychiatric disorders is contraindicated. PRISTIQ should also not be started in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue. All reports with methylene blue that provided information on the route of administration involved intravenous administration in the dose range of 1 mg/kg to 8 mg/kg. No reports involved the administration of methylene blue by other routes (such as oral tablets or local tissue injection) or at lower doses. There may be circumstances when it is necessary to initiate treatment with a MAOI such as linezolid or intravenous methylene blue in a patient taking PRISTIQ. PRISTIQ should be discontinued before initiating treatment with the MAOI [see Contraindications (4.2) and Dosage and Administration (2.6) ] .\n\n\n\n If concomitant use of PRISTIQ with other serotonergic drugs, including triptans, tricyclic antidepressants, fentanyl, lithium, tramadol, buspirone, tryptophan, and St. John's Wort is clinically warranted, patients should be made aware of a potential increased risk for serotonin syndrome, particularly during treatment initiation and dose increases.\n\n\n\n Treatment with PRISTIQ and any concomitant serotonergic agents should be discontinued immediately if the above events occur and supportive symptomatic treatment should be initiated.\n\n\n\n 5.3 Elevated Blood Pressure\n\n\n\n Patients receiving PRISTIQ should have regular monitoring of blood pressure since increases in blood pressure were observed in clinical studies [see Adverse Reactions (6.1) ] . Pre-existing hypertension should be controlled before initiating treatment with PRISTIQ. Caution should be exercised in treating patients with pre-existing hypertension, cardiovascular, or cerebrovascular conditions that might be compromised by increases in blood pressure. Cases of elevated blood pressure requiring immediate treatment have been reported with PRISTIQ.\n\n\n\n Sustained blood pressure increases could have adverse consequences. For patients who experience a sustained increase in blood pressure while receiving PRISTIQ, either dose reduction or discontinuation should be considered [see Adverse Reactions (6.1) ] .\n\n\n\n 5.4 Abnormal Bleeding\n\n\n\n SSRIs and SNRIs, including PRISTIQ, may increase the risk of bleeding events. Concomitant use of aspirin, nonsteroidal anti-inflammatory drugs, warfarin, and other anticoagulants may add to this risk. Case reports and epidemiological studies (case-control and cohort design) have demonstrated an association between use of drugs that interfere with serotonin reuptake and the occurrence of gastrointestinal bleeding. Bleeding events related to SSRIs and SNRIs have ranged from ecchymosis, hematoma, epistaxis, and petechiae to life-threatening hemorrhages. Patients should be cautioned about the risk of bleeding associated with the concomitant use of PRISTIQ and NSAIDs, aspirin, or other drugs that affect coagulation or bleeding.\n\n\n\n 5.5 Angle Closure Glaucoma\n\n\n\n Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs including Pristiq may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy. \n\n\n\n 5.6 Activation of Mania/Hypomania\n\n\n\n During all MDD phase 2 and phase 3 studies, mania was reported for approximately 0.02% of patients treated with PRISTIQ. Activation of mania/hypomania has also been reported in a small proportion of patients with major affective disorder who were treated with other marketed antidepressants. As with all antidepressants, PRISTIQ should be used cautiously in patients with a history or family history of mania or hypomania.\n\n\n\n 5.7 Discontinuation Syndrome\n\n\n\n Discontinuation symptoms have been systematically and prospectively evaluated in patients treated with PRISTIQ during clinical studies in Major Depressive Disorder. Abrupt discontinuation or dose reduction has been associated with the appearance of new symptoms that include dizziness, nausea, headache, irritability, insomnia, diarrhea, anxiety, fatigue, abnormal dreams, and hyperhidrosis. In general, discontinuation events occurred more frequently with longer duration of therapy.\n\n\n\n During marketing of SNRIs (Serotonin and Norepinephrine Reuptake Inhibitors), and SSRIs (Selective Serotonin Reuptake Inhibitors), there have been spontaneous reports of adverse events occurring upon discontinuation of these drugs, particularly when abrupt, including the following: dysphoric mood, irritability, agitation, dizziness, sensory disturbances (e.g., paresthesia, such as electric shock sensations), anxiety, confusion, headache, lethargy, emotional lability, insomnia, hypomania, tinnitus, and seizures. While these events are generally self-limiting, there have been reports of serious discontinuation symptoms.\n\n\n\n Patients should be monitored for these symptoms when discontinuing treatment with PRISTIQ. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose, but at a more gradual rate [see Dosage and Administration (2.4) and Adverse Reactions (6.1) ] .\n\n\n\n 5.8 Seizure\n\n\n\n Cases of seizure have been reported in pre-marketing clinical studies with PRISTIQ. PRISTIQ has not been systematically evaluated in patients with a seizure disorder. Patients with a history of seizures were excluded from pre-marketing clinical studies. PRISTIQ should be prescribed with caution in patients with a seizure disorder.\n\n\n\n 5.9 Hyponatremia\n\n\n\n Hyponatremia may occur as a result of treatment with SSRIs and SNRIs, including PRISTIQ. In many cases, this hyponatremia appears to be the result of the syndrome of inappropriate antidiuretic hormone secretion (SIADH). Cases with serum sodium lower than 110 mmol/L have been reported. Elderly patients may be at greater risk of developing hyponatremia with SSRIs and SNRIs. Also, patients taking diuretics or who are otherwise volume depleted can be at greater risk [see Use in Specific Populations (8.5) and Clinical Pharmacology (12.6)] . Discontinuation of PRISTIQ should be considered in patients with symptomatic hyponatremia and appropriate medical intervention should be instituted.\n\n\n\n Signs and symptoms of hyponatremia include headache, difficulty concentrating, memory impairment, confusion, weakness, and unsteadiness, which can lead to falls. Signs and symptoms associated with more severe and/or acute cases have included hallucination, syncope, seizure, coma, respiratory arrest, and death.\n\n\n\n 5.10 Interstitial Lung Disease and Eosinophilic Pneumonia\n\n\n\n Interstitial lung disease and eosinophilic pneumonia associated with venlafaxine (the parent drug of PRISTIQ) therapy have been rarely reported. The possibility of these adverse events should be considered in patients treated with PRISTIQ who present with progressive dyspnea, cough, or chest discomfort. Such patients should undergo a prompt medical evaluation, and discontinuation of PRISTIQ should be considered.\n"
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] |
3 | beleodaq | [
{
"id": "beleodaq_section_S1",
"type": "adverse reactions",
"text": [
" 6 ADVERSE REACTIONS\n\n The following serious adverse reactions are described in more detail in other sections of the prescribing information.\n\n\n\n * Hematologic Toxicity [see Warnings and Precautions ( 5.1 )] \n * Infection [see Warnings and Precautions ( 5.2 )] \n * Hepatotoxicity [see Warnings and Precautions ( 5.3 )] \n * Tumor Lysis Syndrome [see Warnings and Precautions ( 5.4 )] \n * Gastrointestinal Toxicity [see Warnings and Precautions ( 5.5 )] \n The most common adverse reactions observed in the trial of patients with relapsed or refractory PTCL treated with Beleodaq were nausea, fatigue, pyrexia, anemia, and vomiting [see Clinical Studies ( 14 ) ] .\n \n\n EXCERPT: The most common adverse reactions (>25%) are nausea, fatigue, pyrexia, anemia, and vomiting. ( 6 )\n\n\n\n To report SUSPECTED ADVERSE REACTIONS, contact Spectrum Pharmaceuticals, Inc. at 1-888-292-9617 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch \n\n\n\n \n\n 6.1 Clinical Trials Experience\n\n Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of Beleodaq may not reflect the rates observed in practice.\n\n\n\n Adverse Reactions in Patients with Peripheral T-Cell Lymphoma \n\n\n\n The safety of Beleodaq was evaluated in 129 patients with relapsed or refractory PTCL in the single arm clinical trial in which patients were administered Beleodaq at a dosage of 1,000 mg/m2 administered over 30 minutes by IV infusion once daily on Days 1-5 of a 21-day cycle [see Clinical Studies ( 14 ) ] . The median duration of treatment was 2 cycles (range 1 - 33 cycles).\n\n\n\n Table 2 summarizes the adverse reactions regardless of causality from the trial in patients with relapsed or refractory PTCL.\n\n\n\n Table 2: Adverse Reactions Occurring in >= 10% of Patients by Preferred Term and Severity in Patients with Relapsed or Refractory PTCL (NCI-CTC Grade 1-4) \n MedDRA Preferred Term Percentage of Patients (%) (N=129) \n All Grades Grade 3 or 4 \n All Adverse Reactions 97 61 \n Nausea 42 1 \n Fatigue 37 5 \n Pyrexia 35 2 \n Anemia 32 11 \n Vomiting 29 1 \n Constipation 23 1 \n Diarrhea 23 2 \n Dyspnea 22 6 \n Rash 20 1 \n Peripheral Edema 20 0 \n Cough 19 0 \n Thrombocytopenia 16 7 \n Pruritus 16 3 \n Chills 16 1 \n Increased Blood Lactate Dehydrogenase 16 2 \n Decreased Appetite 15 2 \n Headache 15 0 \n Infusion Site Pain 14 0 \n Hypokalemia 12 4 \n Prolonged QT 11 4 \n Abdominal pain 11 1 \n Hypotension 10 3 \n Phlebitis 10 1 \n Dizziness 10 0 \n Note: Adverse reactions are listed by order of incidence in the \"All Grades\" category first, then by incidence in \"the Grade 3 or 4\" category; MedDRA = Medical Dictionary for Regulatory Activities; Severity measured by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3.0\n \n\n Serious Adverse Reactions \n\n\n\n Sixty-one patients (47.3%) experienced serious adverse reactions while taking Beleodaq or within 30 days after their last dose of Beleodaq. The most common serious adverse reactions (> 2%) were pneumonia, pyrexia, infection, anemia, increased creatinine, thrombocytopenia, and multi-organ failure. One treatment-related death associated with hepatic failure was reported in the trial.\n\n\n\n One patient with baseline hyperuricemia and bulky disease experienced Grade 4 tumor lysis syndrome during the first cycle of treatment and died due to multi-organ failure. A treatment-related death from ventricular fibrillation was reported in another monotherapy clinical trial with Beleodaq. ECG analysis did not identify QTc prolongation.\n\n\n\n Discontinuations due to Adverse Reactions \n\n\n\n Twenty-five patients (19.4%) discontinued treatment with Beleodaq due to adverse reactions. The adverse reactions reported most frequently as the reason for discontinuation of treatment included anemia, febrile neutropenia, fatigue, and multi-organ failure.\n\n\n\n Dosage Modifications due to Adverse Reactions \n\n\n\n In the trial, dosage adjustments due to adverse reactions occurred in 12% of Beleodaq-treated patients.\n"
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"id": "beleodaq_section_S2",
"type": "warnings and precautions",
"text": [
" 5 WARNINGS AND PRECAUTIONS\n\n\n\n EXCERPT: * Thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia: Monitor blood counts and modify dosage for hematologic toxicities. ( 2.2 , 5.1 ) \n * Infection: Serious and fatal infections (e.g., pneumonia and sepsis). ( 5.2 ) \n * Hepatotoxicity: Beleodaq may cause hepatic toxicity and liver function test abnormalities. Monitor liver function tests and omit or modify dosage for hepatic toxicities. ( 2.2 , 5.3 ) \n * Tumor lysis syndrome: Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions. ( 5.4 ) \n * Embryo-fetal toxicity: Beleodaq may cause fetal harm when administered to a pregnant woman. Advise women of potential harm to the fetus and to avoid pregnancy while receiving Beleodaq. ( 5.6 ) \n \n \n\n 5.1 Hematologic Toxicity\n\n\n\n Beleodaq can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and/or anemia; monitor blood counts weekly during treatment, and modify dosage as necessary [see Dosage and Administration ( 2.2 ) and Adverse Reactions ( 6.1 )] .\n\n\n\n 5.2 Infections\n\n\n\n Serious and sometimes fatal infections, including pneumonia and sepsis, have occurred with Beleodaq. Do not administer Beleodaq to patients with an active infection. Patients with a history of extensive or intensive chemotherapy may be at higher risk of life threatening infections [see Adverse Reactions ( 6.1 )]. \n\n\n\n 5.3 Hepatotoxicity\n\n\n\n Beleodaq can cause fatal hepatotoxicity and liver function test abnormalities [see Adverse Reactions ( 6.1 )] . Monitor liver function tests before treatment and before the start of each cycle. Interrupt or adjust dosage until recovery, or permanently discontinue Beleodaq based on the severity of the hepatic toxicity [see Dosage and Administration ( 2.2) ]. \n\n\n\n 5.4 Tumor Lysis Syndrome\n\n\n\n Tumor lysis syndrome has occurred in Beleodaq-treated patients in the clinical trial of patients with relapsed or refractory PTCL [see Clinical Studies ( 14 ) ] . Monitor patients with advanced stage disease and/or high tumor burden and take appropriate precautions [see Adverse Reactions ( 6.1 ) ] .\n\n\n\n 5.5 Gastrointestinal Toxicity\n\n\n\n Nausea, vomiting and diarrhea occur with Beleodaq [see Adverse Reactions ( 6.1 )] and may require the use of antiemetic and antidiarrheal medications.\n\n\n\n 5.6 Embryo-fetal Toxicity\n\n\n\n Beleodaq can cause fetal harm when administered to a pregnant woman. Beleodaq may cause teratogenicity and/or embryo-fetal lethality because it is genotoxic and targets actively dividing cells [see Nonclinical Toxicology ( 13.1 ) ] . Women of childbearing potential should be advised to avoid pregnancy while receiving Beleodaq. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of potential hazard to the fetus [see Use in Specific Populations ( 8.1 ) ] .\n"
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4 | picato | [
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" 6 ADVERSE REACTIONS \n\n \n\n\n\n The following serious adverse reactions are discussed in more detail in other sections of the labeling:\n\n\n\n \n\n\n\n * Ophthalmic Adverse Reaction [see Warnings and Precautions ( 5.1 )] \n * Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 )] \n \n \n\n EXCERPT: The most common adverse reactions (>=2 %) are local skin reactions, application site pain, application site pruritus, application site irritation, application site infection, periorbital edema, nasopharyngitis and headache. ( 6.1 )\n\n\n\n To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. \n\n\n\n \n\n 6.1 Clinical Trials Experience\n\n Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.\n\n\n\n \n\n\n\n The data described below reflect exposure to Picato (r) gel in 499 subjects with actinic keratosis, including 274 subjects exposed to Picato (r) gel field treatment (skin area of 25 cm 2 in the face or scalp regions) at a concentration of 0.015% once daily for 3 consecutive days, and 225 subjects exposed to Picato (r) gel field treatment (skin area of 25 cm 2 in the trunk or extremities regions) at a concentration of 0.05% once daily for 2 consecutive days.\n\n\n\n \n\n\n\n Local skin reactions, including erythema, flaking/scaling, crusting, swelling, vesiculation/pustulation, and erosion/ulceration were assessed within the selected treatment area and graded by the investigator on a scale of 0 to 4. A grade of 0 represented no reaction present in the treated area, and a grade of 4 indicated a marked and severe skin reaction that extended beyond the treated area.\n\n\n\n \n\n\n\n Table 1 Investigator Assessment of Maximal Local Skin Reactions in the Treatment Area during the 57 Days Post Treatment Period (face/scalp trials) \n\n\n\n\n Face and Scalp (n=545) Picato(r) gel, 0.015% once daily for 3 days \n Skin reactions Any Gradea > Baseline Grade 4 \n Picato(r) gel (n=274) Vehicle (n=271) Picato(r) gel (n=274) Vehicle (n=271) \n Erythema 258 (94%) 69 (25%) 66 (24%) 0 (0%) \n Flaking/Scaling 233 (85%) 67 (25%) 25 (9%) 0 (0%) \n Crusting 220 (80%) 46 (17%) 16 (6%) 0 (0%) \n Swelling 217 (79%) 11 (4%) 14 (5%) 0 (0%) \n Vesiculation/Pustulation 154 (56%) 1 (0%) 15 (5%) 0 (0%) \n Erosion/Ulceration 87 (32%) 3 (1%) 1 (0%) 0 (0%) \n a Mild (grade 1), Moderate (grade 2-3) or Severe (grade 4).\n \n\n \n\n\n\n Table 2 Investigator Assessment of Maximal Local Skin Reactions in the Treatment Area during the 57 Days Post Treatment Period (trunk/extremities trials) \n\n\n\n\n Trunk and Extremities (n=457) Picato(r) gel, 0.05% once daily for 2 days \n Skin reactions Any Gradea > Baseline Grade 4 \n Picato(r) gel (n=225) Vehicle (n=232) Picato(r) gel (n=225) Vehicle (n=232) \n Erythema 207 (92%) 43 (19%) 34 (15%) 0 (0%) \n Flaking/Scaling 203 (90%) 44 (19%) 18 (8%) 0 (0%) \n Crusting 167 (74%) 23 (10%) 8 (4%) 0 (0%) \n Swelling 143 (64%) 13 (6%) 7 (3%) 0 (0%) \n Vesiculation/Pustulation 98 (44%) 2 (1%) 3 (1%) 0 (0%) \n Erosion/Ulceration 58 (26%) 6 (3%) 2 (1%) 0 (0%) \n a Mild (grade 1), Moderate (grade 2-3) or Severe (grade 4).\n \n\n \n\n\n\n Local skin reactions typically occurred within 1 day of treatment initiation, peaked in intensity up to 1 week following completion of treatment, and resolved within 2 weeks for areas treated on the face and scalp, and within 4 weeks for areas treated on the trunk and extremities.\n\n\n\n \n\n\n\n Adverse reactions that occurred in >=2% of subjects treated with Picato (r) gel and at a higher frequency than the vehicle are presented in Table 3 and Table 4.\n\n\n\n \n\n\n\n Table 3 Adverse reactions occurring in >= 2% of subjects treated with Picato (r) gel and at higher frequency than vehicle (face/scalp trials) \n\n\n\n\n Face/Scalp \n Adverse Reactions Picato(r) gel, 0.015% (N=274) Vehicle (N=271) \n \n Application Site Pain 42 (15%) 1 (0%) \n Application Site Pruritus 22 (8%) 3 (1%) \n Application Site Infection 7 (3%) 0 (0%) \n Periorbital Edema 7 (3%) 0 (0%) \n Headache 6 (2%) 3 (1%) \n \n \n\n Table 4 Adverse reactions occurring in >= 2% of subjects treated with Picato (r) gel and at higher frequency than vehicle (trunk/extremities trials) \n\n\n\n\n Trunk/Extremities \n Adverse Reactions Picato(r) gel, 0.05% (N=225) Vehicle (N=232) \n Application Site Pruritus 18 (8%) 0 (0%) \n Application Site Irritation 8 (4%) 1 (0%) \n Nasopharyngitis 4 (2%) 2 (1%) \n Application Site Pain 5 (2%) 0 (0%) \n \n \n\n Less common adverse reactions in subjects treated with Picato (r) included: eyelid edema, eye pain, conjunctivitis.\n\n\n\n \n\n\n\n A total of 108 subjects treated with Picato (r) gel on the face/scalp and 38 subjects treated on the trunk/extremities were followed for 12 months. Results from these studies did not change the safety profile of Picato (r) gel.\n\n\n\n 6.2 Postmarketing Experience\n\n The following adverse reactions have been identified during post approval use of Picato (r) (ingenol mebutate) gel, 0.015% and 0.05%: hypersensitivity, allergic contact dermatitis, herpes zoster, chemical conjunctivitis, and corneal burn.\n\n\n\n Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.\n"
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" 5 WARNINGS AND PRECAUTIONS \n\n\n\n EXCERPT: Avoid treatment in the periocular area. Eye disorders, including severe eye pain, chemical conjunctivitis, corneal burn, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure. Avoid accidental transfer of the drug into the eyes and to the periocular area. If accidental exposure occurs, flush eyes with water and seek medical care. ( 5.1 )\n\n\n\n \n\n\n\n Local skin reactions can occur including severe reactions (e.g., vesiculation/pustulation, erosion/ulceration). Administration of Picato (r) gel is not recommended until skin is healed from any previous drug or surgical treatment. ( 5.3 )\n\n\n\n \n\n\n\n 5.1 Ophthalmic Adverse Reactions\n\n\n\n Avoid treatment in the periocular area. Eye disorders, including severe eye pain, chemical conjunctivitis, corneal burn, eyelid edema, eyelid ptosis, periorbital edema can occur after exposure [see Adverse Reactions ( 6 )] . \n\n\n\n \n\n\n\n To avoid transfer of the drug into the eyes and to the periocular area during and after application, patients should wash hands well after applying Picato (r) gel. If accidental exposure occurs, the area should be flushed with water and the patient should seek medical care as soon as possible. \n\n\n\n 5.2 Hypersensitivity Reactions\n\n\n\n Hypersensitivity reactions, including anaphylaxis and allergic contact dermatitis, have been reported post-marketing [see Adverse Reactions ( 6.2 )] . If anaphylactic or other clinically significant hypersensitivity reactions occur, discontinue Picato (r) immediately and institute appropriate medical therapy.\n\n\n\n 5.3 Local Skin Reactions\n\n\n\n Severe skin reactions in the treated area, including erythema, crusting, swelling, vesiculation/postulation, and erosion/ulceration, can occur after topical application of Picato (r) gel [see Adverse Reactions ( 6 )] . Administration of Picato (r) gel is not recommended until the skin is healed from any previous drug or surgical treatment.\n"
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] | [] | [] | [
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{
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}
] |
5 | dysport | [{"id":"dysport_section_S1","type":"adverse reactions","text":[" 6 ADVERSE REACTIONS\n\n The fol(...TRUNCATED) | [{"id":"dysport_entity_M1","type":"AdverseReaction","text":["Distant Spread of Toxin Effect"],"offse(...TRUNCATED) | [] | [] | [{"id":"dysport_relation_RL1","type":"Effect","arg1_id":"M76","arg2_id":"M75","normalized":[]},{"id"(...TRUNCATED) |
6 | xtandi | [{"id":"xtandi_section_S1","type":"adverse reactions","text":[" 6 ADVERSE REACTIONS\n\n The foll(...TRUNCATED) | [{"id":"xtandi_entity_M1","type":"AdverseReaction","text":["Seizure"],"offsets":[[113,120]],"normali(...TRUNCATED) | [] | [] | [{"id":"xtandi_relation_RL1","type":"Effect","arg1_id":"M134","arg2_id":"M132","normalized":[]},{"id(...TRUNCATED) |
7 | stendra | [{"id":"stendra_section_S1","type":"adverse reactions","text":[" 6 ADVERSE REACTIONS\n\n EXCERPT(...TRUNCATED) | [{"id":"stendra_entity_M1","type":"AdverseReaction","text":["headache"],"offsets":[[106,114]],"norma(...TRUNCATED) | [] | [] | [{"id":"stendra_relation_RL1","type":"Hypothetical","arg1_id":"M81","arg2_id":"M85","normalized":[]}(...TRUNCATED) |
8 | potiga | [{"id":"potiga_section_S1","type":"adverse reactions","text":[" 6 ADVERSE REACTIONS\n\n The foll(...TRUNCATED) | [{"id":"potiga_entity_M1","type":"AdverseReaction","text":["Retinal abnormalities"],"offsets":[[153,(...TRUNCATED) | [] | [] | [{"id":"potiga_relation_RL1","type":"Hypothetical","arg1_id":"M3","arg2_id":"M2","normalized":[]},{"(...TRUNCATED) |
9 | dalvance | [{"id":"dalvance_section_S1","type":"adverse reactions","text":[" 6 ADVERSE REACTIONS\n\n Becaus(...TRUNCATED) | [{"id":"dalvance_entity_M1","type":"AdverseReaction","text":["nausea"],"offsets":[[375,381]],"normal(...TRUNCATED) | [] | [] | [{"id":"dalvance_relation_RL1","type":"Effect","arg1_id":"M42","arg2_id":"M43","normalized":[]},{"id(...TRUNCATED) |
End of preview. Expand
in Dataset Viewer.
Dataset Card for SPL ADR
The United States Food and Drug Administration (FDA) partnered with the National Library of Medicine to create a pilot dataset containing standardised information about known adverse reactions for 200 FDA-approved drugs. The Structured Product Labels (SPLs), the documents FDA uses to exchange information about drugs and other products, were manually annotated for adverse reactions at the mention level to facilitate development and evaluation of text mining tools for extraction of ADRs from all SPLs. The ADRs were then normalised to the Unified Medical Language System (UMLS) and to the Medical Dictionary for Regulatory Activities (MedDRA).
Citation Information
@article{demner2018dataset,
author = {Demner-Fushman, Dina and Shooshan, Sonya and Rodriguez, Laritza and Aronson,
Alan and Lang, Francois and Rogers, Willie and Roberts, Kirk and Tonning, Joseph},
title = {A dataset of 200 structured product labels annotated for adverse drug reactions},
journal = {Scientific Data},
volume = {5},
year = {2018},
month = {01},
pages = {180001},
url = {
https://www.researchgate.net/publication/322810855_A_dataset_of_200_structured_product_labels_annotated_for_adverse_drug_reactions
},
doi = {10.1038/sdata.2018.1}
}
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