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        Drug Safety and Availability

FDA Drug Safety Podcasts Home
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          Drug Safety and Availability
          FDA Drug Safety PodcastsDrug Safety and Availability FDA Drug Safety Podcasts
  	
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    PrintThe FDA Drug Safety Podcasts are produced by FDA's Center for Drug Evaluation and Research (CDER). They provide emerging safety information about drugs in conjunction with the release of Drug Safety Communications.







Latest Drug Safety Podcasts
	Title
			Date
			Podcast
			TranscriptUpdate on FDA’s ongoing evaluation of reports of suicidal thoughts or actions in patients taking a certain type of medicines approved for type 2 diabetes and obesity
			January 11, 2024
			Listen
			Run Time:
			00:3:30
			TranscriptFDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
			November 28, 2023
			Listen
			Run Time:
			00:5:05
			TranscriptFDA updating warnings to improve safe use of prescription stimulants used to treat ADHD and other conditions
			May 11, 2023
			Listen
			Run Time:
			00:5:30
			TranscriptFDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use
			April 13, 2023
			Listen
			Run Time:
			00:7:30
			TranscriptFDA investigating risk of severe hypocalcemia in patients on dialysis receiving osteoporosis medicine Prolia (denosumab)
			November 22, 2022
			Listen
			Run Time:
			00:4:00
			TranscriptFDA warns about possible increased risk of death and serious side effects with cancer drug Copiktra (duvelisib)
			June 30, 2022
			Listen
			Run Time:
			00:4:00
			TranscriptFDA withdrew its approval for the cancer medicine Ukoniq (umbralisib) due to safety concerns
			June 1, 2022
			Listen
			Run Time:
			00:2:00
			TranscriptFDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imaging
			March 30, 2022
			Listen
			Run Time:
			00:4:30
			TranscriptFDA investigating possible increased risk of death with lymphoma medicine Ukoniq (umbralisib)
			February 3, 2022
			Listen
			Run Time:
			00:3:30
			TranscriptFDA warns about dental problems with buprenorphine medicines dissolved in the mouth to treat opioid use disorder and pain
			January 12, 2022
			Listen
			Run Time:
			00:5:59
			TranscriptFDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injury
			November 2, 2021
			Listen*Run Time:
			00:4:00*
			TranscriptFDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditions
			September 1, 2021
			Listen*Run Time:
			00:4:00*
			TranscriptFDA requests removal of strongest warning against using cholesterol-lowering statins during pregnancy; still advises most pregnant patients should stop taking statins
			July 20, 2021
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns that vapors from alcohol-based hand sanitizers can have side effects
			June 16, 2021
			Listen*Run Time:
			00:4:29*
			TranscriptDue to risk of serious liver injury, FDA restricts use of obeticholic acid (Ocaliva) in primary biliary cholangitis (PBC) patients with advanced cirrhosis
			May 26, 2021
			Listen*Run Time:
			00:3:38*
			TranscriptStudies show increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart disease
			March 31, 2021
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns that abuse and misuse of the OTC nasal decongestant propylhexedrine can lead to serious harm
			March 25, 2021
			Listen*Run Time:
			00:3:00*
			TranscriptInitial safety trial results find increased risk of serious heart-related problems and cancer with arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib)
			February 4, 2021
			Listen*Run Time:
			00:3:00*
			TranscriptFDA recommends avoiding use of NSAIDs in pregnancy at 20 weeks or later because they can result in low amniotic fluid
			October 15, 2020
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about serious problems with high doses of the allergy medicine diphenhydramine (Benadryl)
			September 24, 2020
			Listen*Run Time:
			00:3:00*
			TranscriptFDA requiring Boxed Warning updated to improve safe use of benzodiazepine drug class
			September 23, 2020
			Listen*Run Time:
			00:3:00*
			TranscriptFDA removes Boxed Warning about risk of leg and foot amputations for the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
			August 26, 2020
			Listen*Run Time:
			00:2:59*
			TranscriptFDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorder
			July 23, 2020
			Listen*Run Time:
			00:3:31*
			TranscriptFDA cautions against use of hydroxychloroquine or chloroquine for COVID-19 outside of the hospital setting or a clinical trial due to risk of heart rhythm problems
			April 24, 2020
			Listen*Run Time:
			00:3:32*
			TranscriptFDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitis
			March 4, 2020
			Listen*Run Time:
			00:3:00*
			TranscriptFDA requests the withdrawal of the weight-loss drug Belviq, Belviq XR (lorcaserin) from the market
			February 13, 2020
			Listen*Run Time:
			00:3:00*
			TranscriptFDA strengthens warning that untreated constipation caused by schizophrenia medicine clozapine (Clozaril) can lead to serious bowel problems
			January 28, 2020
			Listen*Run Time:
			00:3:00*
			TranscriptSafety clinical trial shows possible increased risk of cancer with weight-loss medicine Belviq, Belviq XR (lorcaserin)
			January 14, 2020
			Listen*Run Time:
			00:2:00*
			TranscriptFDA warns about serious breathing problems with seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)
			December 19, 2019
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about rare but severe lung inflammation with Ibrance, Kisqali, and Verzenio for breast cancer
			September 13, 2019
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver disease
			August 28, 2019
			Listen*Run Time:
			00:3:00*
			TranscriptFDA review finds no increased risk of prostate cancer with Parkinson's disease medicines containing entacapone (Comtan, Stalevo)
			August 13, 2019
			Listen*Run Time:
			00:3:00*
			TranscriptFDA approves Boxed Warning about increased risk of blood clots and death with higher dose of arthritis and ulcerative colitis medicine tofacitinib (Xeljanz, Xeljanz XR)
			July 26, 2019
			Listen*Run Time:
			00:3:00*
			TranscriptFDA adds Boxed Warning for risk of serious injuries caused by sleepwalking with certain prescription insomnia medicines
			April 30, 2019
			Listen*Run Time:
			00:3:00*
			TranscriptFDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized tapering
			April 9, 2019
			Listen*Run Time:
			00:3:00*
			TranscriptSafety trial finds risk of blood clots in the lungs and death with higher dose of tofacitinib (Xeljanz, Xeljanz XR) in rheumatoid arthritis patients; FDA to investigate
			February 25, 2019
			Listen*Run Time:
			00:3:00*
			TranscriptFDA adds Boxed Warning for increased risk of death with gout medicine Uloric (febuxostat)
			February 21, 2019
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)
			November 29, 2018
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about rare but serious risks of stroke and blood vessel wall tears with multiple sclerosis drug Lemtrada (alemtuzumab)
			November 29, 2018
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)
			November 20, 2018
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about rare occurrences of a serious infection of the genital area with SGLT2 inhibitors for diabetes
			August 29, 2018
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplant
			August 3, 2018
			Listen*Run Time:
			00:3:00*
			TranscriptFDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes
			July 10, 2018
			Listen*Run Time:
			00:3:00*
			TranscriptRisk of serious and potentially fatal blood disorder prompts FDA action on oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics
			May 23, 2018
			Listen*Run Time:
			00:3:00*
			TranscriptFDA to evaluate potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)
			May 18, 2018
			Listen*Run Time:
			00:3:30*
			TranscriptFDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal)
			April 25, 2018
			Listen*Run Time:
			00:3:00*
			TranscriptFDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease
			February 22, 2018
			Listen*Run Time:
			00:2:00*
			TranscriptFDA adds Boxed Warning to highlight correct dosing of Ocaliva (obeticholic acid) for patients with a rare chronic liver disease
			February 1, 2018
			Listen*Run Time:
			00:3:00*
			TranscriptFDA limits packaging for anti-diarrhea medicine Loperamide (Imodium) to encourage safe use
			January 30, 2018
			Listen*Run Time:
			00:3:00*
			TranscriptFDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older
			January 11, 2018
			Listen*Run Time:
			00:3:09*
			TranscriptFDA review finds no significant increase in risk of serious asthma outcomes with long-acting beta agonists (LABAs) used in combination with inhaled corticosteroids (ICS)
			December 20, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warnings
			December 19, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA to evaluate increased risk of heart-related death and death from all causes with the gout medicine febuxostat (Uloric)
			November 15, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about serious liver injury with Ocaliva (obeticholic acid) for rare chronic liver disease
			September 21, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA urges caution about withholding opioid addiction medications from patients taking benzodiazepines or CNS depressants: careful medication management can reduce risks
			September 20, 2017
			Listen*Run Time:
			00:3:30*
			TranscriptFDA recommends separating dosing of potassium-lowering drug sodium polystyrene sulfonate (Kayexalate) from all other oral drugs
			September 6, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continue
			May 22, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA confirms increased risk of leg and foot amputations with the diabetes medicine canagliflozin (Invokana, Invokamet, Invokamet XR)
			May 16, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA approves label changes for use of general anesthetic and sedation drugs in young children
			April 27, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding women
			April 20, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about increased risk of serious pancreatitis with irritable bowel drug Viberzi (eluxadoline) in patients without a gallbladder
			March 15, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about rare but serious allergic reactions with the skin antiseptic chlorhexidine gluconate
			February 2, 2017
			Listen*Run Time:
			00:3:00*
			TranscriptFDA revises description of mental health side effects of stop-smoking medicines Chantix and Zyban to reflect clinical trial findings
			December 16, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant women
			December 14, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptUpdated FDA review concludes that use of pioglitazone may be linked to an increased risk of bladder cancer
			December 12, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about the risk of hepatitis B reactivating in some patients treated with direct-acting antivirals for hepatitis C
			October 4, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warning
			August 31, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects
			July 26, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA strengthens kidney warnings for diabetes medicines canagliflozin (Invokana, Invokamet) and dapagliflozin (Farxiga, Xigduo XR)
			June 14, 2016
			Listen*Run Time:
			00:3:04*
			TranscriptUpdate: FDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
			June 10, 2016
			Listen*Run Time:
			00:1:12*
			TranscriptFDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse
			June 7, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about serious bleeding risk with over-the-counter antacid products containing aspirin
			June 6, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA evaluating the risk of burns and scars with Zecuity (sumatriptan) migraine patch
			June 2, 2016
			Listen*Run Time:
			00:1:58*
			TranscriptFDA warns that prescribing of Nizoral (ketoconazole) oral tablets for unapproved uses including skin and nail infections continues; linked to patient death
			May 19, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptInterim clinical trial results find increased risk of leg and foot amputations, mostly affecting the toes, with the diabetes medicine canagliflozin (Invokana, Invokamet); FDA to investigate
			May 18, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together
			May 12, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)
			May 10, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)
			May 3, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA approves brand name change for antidepressant drug Brintellix (vortioxetine) to avoid confusion with antiplatelet drug Brilinta (ticagrelor)
			May 2, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA to review study examining use of oral fluconazole (Diflucan) in pregnancy
			April 26, 2016
			Listen*Run Time:
			00:2:00*
			TranscriptFDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney function
			April 8, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA announced that a safety review has found type 2 diabetes medicines containing saxagliptin and alogliptin may increase the risk of heart failure
			April 5, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA warns about several safety issues with opioid pain medicines; requires label changes
			March 29, 2016
			Listen*Run Time:
			00:3:00*
			TranscriptFDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved
			January 4, 2016
			Listen*Run Time:
			00:3:00*
			Transcript

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	Drug Safety CommunicationsFDA warns that symptoms of a serious condition affecting the blood cells are not being recognized with the leukemia medicine Idhifa (enasidenib)

                                                                                  Content current as of:
      01/26/2024
                  
                   
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