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                Pediatrics

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          FDA Pediatric Safety CommunicationsPediatrics FDA Pediatric Safety Communications
  
  	
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			Product(s)
			AnnouncementJanuary 9, 2024
			GE HealthCare EVair and EVair03 Compressors with Certain Ventilators
			FDA alerts health care providers about potential exposure to certain chemicals with use of GE HealthCare EVair and EVair03 Compressors with certain ventilators – Letter to Health Care ProvidersJanuary 8, 2024
			Mega Soft Universal Patient Return Electrode
			FDA reports that Megadyne Medical Products, Inc. has recalled Mega Soft Universal Patient Return Electrode due to reports of patient burnsJanuary 5, 2024
			Recalled WanaBana apple cinnamon fruit puree pouches- including three packs, Recalled Schnucks-brand cinnamon-flavored applesauce pouches and variety pack, Recalled Weis-brand cinnamon applesauce pouches
			FDA reports that recalled cinnamon apple puree and applesauce products containing lead test positive for chromiumJanuary 3, 2024
			Neonatal incubators
			FDA updates healthcare providers about its ongoing evaluation of airborne chemicals from neonatal incubators - Letter to Health Care ProvidersDecember 31, 2023
			Select batches of Nutramigen hypoallergenic infant formula powder
			FDA reports that Reckitt/Mead Johnson Nutrition has voluntarily recalled select batches of Nutramigen hypoallergenic infant formula powder because of possible health riskDecember 14, 2023
			Levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)
			FDA 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
			BCMA-directed or CD-19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies
			FDA is investigating serious risk of T-cell malignancy following BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapiesNovember 3, 2023
			WanaBana Apple Cinnamon Fruit Puree Pouches
			FDA advises parents and caregivers not to buy or feed WanaBana Apple Cinnamon Fruit Puree Pouches to toddlers and young children because of elevated lead levelsNovember 1, 2023
			Moderna COVID-19 vaccine (2023-2024 Formula)
			FDA advises health care providers about the correct dosage and administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for individuals 6 months through 11 years of ageOctober 26, 2023
			Probiotics
			FDA raises concerns about probiotic products sold for use in hospitalized preterm infants.-September 29, 2023: Dear Healthcare Provider LetterOctober 16, 2023
			Neonatal incubators
			FDA provides an update about the evaluation of Airborne Chemicals from Neonatal Incubators - Letter to Health Care Providers- **UPDATE October 16, 2023**September 14, 2023
			LittleOak infant formula
			FDA alerts parents and caregivers to concerns regarding LittleOak Infant FormulaSeptember 13, 2023
			TheraBreath Strawberry Splash for Kids 16oz
			FDA reports that Church & Dwight issues voluntary nationwide recall of one specific lot of TheraBreath Strawberry Splash for Kids 16oz sold exclusively on Amazon Between May 31 and September 02, 2023, due to microbial contamination identified as yeast (candida parapsilosis)September 29, 2023
			Certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks
			FDA provides an update on recommendations for certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face maskAugust 1, 2023
			GoHealthy probiotics for infants, toddlers and kids in 2-ounce bottles and GoHealthy probiotics for infants, kids, men and women in 4-ounce bottles
			FDA reports that Ozona Organics issues voluntary recall of select liquid probiotic products due to possible health riskJuly 13, 2023
			NOxBOXi Nitric Oxide System
			FDA reports that NOxBOX Ltd. is recalling NOxBOXi Nitric Oxide System for manifold failure that may cause gas leaks and interrupt therapy to neonatesJuly 7, 2023
			Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation)
			FDA reports that Cipla issues voluntary nationwide recall of six batches of Albuterol Sulfate Inhalation Aerosol, 90 mcg (200 Metered Inhalation) due to container defectJune 22, 2023
			Elf Bars and Esco Bars e-cigarettes
			FDA inspection blitz leads to more than 180 warning letters to retailers for the illegal sale of youth-appealing Elf Bar and Esco Bars e-cigarettesJune 13, 2023
			Neonatal incubators
			FDA provides an update about the ongoing evaluation of airborne chemicals from neonatal incubators – Letter to Health Care ProvidersMay 11, 2023
			Prescription stimulant medications
			FDA updates warnings to improve safe use of prescription stimulants used to treat ADHD and other conditionsApril 13, 2023
			Opioid pain medicines
			FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe useApril 12, 2023
			Abbott FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash glucose monitoring system readers
			FDA reports that Abbott has recalled the readers used with the FreeStyle Libre, FreeStyle Libre 14 day, and FreeStyle Libre 2 Flash glucose monitoring systems for risk of extreme heat and fireIssued April 12, 2023; Updated April 21, 2023
			Certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masks
			FDA reports a risk of protection failure with certain O&M Halyard surgical N95 respirators, surgical masks, and pediatric face masksMarch 17, 2023
			Gerber® Good Start® SootheProTM Powdered Infant Formula
			FDA reports that Perrigo announces voluntary recall of limited quantity of Gerber® Good Start® SootheProTM powdered infant formulaMarch 3, 2023
			All allergenic extracts for diagnosis of food allergy
			FDA requires warning about anaphylaxis following false negative food allergen skin test results in the prescribing information for all allergenic extracts for diagnosis of food allergyFebruary 23, 2023
			Neonatal incubators
			FDA informs health care providers and facilities about the potential for exposure to airborne chemicals that may be released from neonatal incubators- **Letter to Health Care Providers**February 20, 2023
			Prosobee 12.9 oz Simply Plant Based Infant Formula
			FDA reports that Reckitt is recalling two batches of Prosobee 12.9 oz Simply Plant Based Infant Formula because of possible health riskFebruary 9, 2023
			Hospira's unapproved Potassium Phosphates drug product
			FDA warns that infants may be at risk for aluminum toxicity when using unapproved potassium phosphates drug productJanuary 30, 2023
			Banana Boat Hair & Scalp Sunscreen
			FDA reports that Edgewell Personal Care has issued a voluntary nationwide recall of Banana Boat Hair & Scalp Sunscreen due to the presence of benzene **UPDATED**November 3, 2022
			Infant Head Shaping Pillows
			FDA recommends not to use infant head shaping pillows to prevent or treat any medical conditionSeptember 6, 2022
			Mother’s Touch formula
			FDA advises parents and caregivers not to buy or give Mother’s Touch formula to infantsAugust 18, 2022
			VPR Brands LP (“Krave Nic”) flavored nicotine gummies
			FDA warns manufacturer for marketing illegal flavored nicotine gummiesAugust 16, 2022
			Capri Sun wild cherry flavored juice drink blend
			FDA reports that Kraft Heinz is announcing a voluntary recall of Capri Sun Wild Cherry flavored juice drink blend beverages due to potential for chemical contaminantsAugust 11, 2022
			At-Home COVID-19 antigen tests
			FDA advises steps to take reduce your risk of false negative At-Home COVID-19 antigen testsAugust 04, 2022
			Major Pharmaceuticals Milk of Magnesia oral suspension
			FDA reports that Plastikon Healthcare expands voluntary nationwide recall of Milk of Magnesia oral suspension and Magnesium Hydroxide /Aluminum Hydroxide /Simethicone oral suspension due to microbial contaminationJuly 29, 2022
			Banana Boat Hair & Scalp sunscreen
			FDA reports that Edgewell Personal Care issued a voluntary nationwide recall of Banana Boat Hair & Scalp Sunscreen due to the presence of benzeneJuly 1, 2022
			Plug Heist Trap House homemade infant formula
			FDA issues an alert on homemade infant formula from Plug Heist Trap House EST. 2017June 28, 2022
			Baby neck floats
			FDA warns to not use baby neck floats due to the risk of death or injuryApril 19, 2022
			Genetic non-invasive prenatal screening (NIPS) tests
			FDA warns that genetic non-invasive prenatal screening tests may have incorrect resultsApril 12, 2022
			Insulin Glargine (Insulin glargine-yfgn) injection
			FDA reports that Mylan Pharmaceuticals Inc., a Viatris Company, conducting voluntary nationwide recall of one batch of Insulin Glargine (Insulin glargine-yfgn) injection, 100 units/mL (U-100), due to the potential for a missing label in the batchMarch 30, 2022
			Contrast Media “Dye,” used for X-rays and other medical imaging procedures
			FDA recommends thyroid monitoring in babies and young children who receive injections of iodine-containing contrast media for medical imagingMarch 24, 2022
			Major Pharmaceutical’s Milk of Magnesia oral suspension 2400 mg/30 mL
			FDA reports that Plastikon Healthcare issues voluntary nationwide recall of Milk of Magnesia oral suspension 2400 mg/30 mL, Magnesium Hydroxide 1200mg/Aluminum Hydroxide 1200mg/Simethicone 120mg per 30 mL, and Acetaminophen 650mg/ 20.3mL, Unit Dose Cups, due to microbial contaminationMarch 21, 2022
			SYMJEPI® (Epinephrine) Injection
			FDA reports that Adamis Pharmaceuticals Corporation issues nationwide voluntary recall of SYMJEPI® (Epinephrine) Injection for potential manufacturing defectMarch 18, 2022
			At-home COVID-19 tests
			FDA alerts people to use and store at-home COVID-19 tests properly to avoid potential harmFebruary 17, 2022
			Certain powdered infant formula produced in Abbott Nutrition’s Facility in Sturgis, Michigan
			FDA warns consumers not to use certain powdered infant formula produced in Abbott Nutrition’s facility in Sturgis, MichiganFebruary 8, 2022
			Enteral feeding delivery sets
			FDA warns of potential risk of strangulation in children who use enteral feeding delivery setsDecember 23, 2021
			Healthy Beauty Angel Formula
			FDA issues an alert on “Healthy Beauty” Angel Formula intended for infants and children by Moor HerbsNovember 2, 2021
			Alcohol-based hand sanitizers
			FDA warns that getting alcohol-based hand sanitizer in the eyes can cause serious injuryOctober 8, 2021
			Specific lots of Parent’s Choice rice baby cereal
			FDA reports that Maple Island Inc. issued a voluntary recall of three lots of Parent’s Choice rice baby cerealOctober 5, 2021
			Ellume COVID-19 Home Tests
			FDA reports the potential for false positive results with certain lots of Ellume COVID-19 Home Tests due to a manufacturing issueSeptember 1, 2021
			Xeljanz and Xeljanz XR (tofacitinib)
			FDA requires warnings about increased risk of serious heart-related events, cancer, blood clots, and death for JAK inhibitors that treat certain chronic inflammatory conditionsJuly 15, 2021
			NuVasive MAGEC System Implants
			FDA reports potential concerns with NuVasive MAGEC System ImplantsJuly 14, 2021
			Specific NEUTROGENA® and AVEENO® aerosol sunscreen products
			FDA reports that Johnson & Johnson Consumer Inc. issued a voluntary recall of specific NEUTROGENA® and AVEENO® aerosol sunscreen products due to the presence of benzeneJuly 7, 2021
			Hydroxyethyl starch (HES) products
			FDA requires labeling changes on mortality, kidney injury, and excess bleeding with hydroxyethyl starch productsJune 16, 2021
			Alcohol-based hand sanitizers
			FDA warns that vapors from alcohol-based hand sanitizers can have side effectsJune 14, 2021
			Designed By Nature goat’s milk, cow’s milk and base milk formulas
			FDA reports that Designed By Nature voluntarily recalls goat’s milk, cow’s milk and base milk formulas due to possible health riskMarch 31, 2021
			Lamotrigine (Lamictal)
			An FDA review of studies shows a potential increased risk of heart rhythm problems with seizure and mental health medicine lamotrigine (Lamictal) in patients with heart diseaseMarch 25, 2021
			Propylhexedrine
			FDA warns that abuse and misuse of the nasal decongestant propylhexedrine causes serious harmFebruary 24, 2021
			Homemade infant formula
			FDA advises parents and caregivers to not make or feed homemade infant formula to infantsFebruary 12, 2021
			Pulse oximeters
			FDA informs patients and health care providers about pulse oximeter accuracy and limitationsFebruary 9, 2021
			COVID-19 vaccines
			FDA monitors COVID-19 vaccine safetyJanuary 4, 2021
			Curative SARS-Cov-2 test
			FDA warns of the risk of false results with the Curative SARS-Cov-2 test for COVID-19October 28, 2020
			Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products
			FDA reports that Sunstar Americas, Inc. is voluntarily recalling Paroex® Chlorhexidine Gluconate Oral Rinse USP, 0.12% products due to possible contamination with the bacteria Burkholderia lataSeptember 24, 2020
			Diphenhydramine (Benadryl)
			FDA warns about serious problems with higher than recommended doses of the allergy medicine diphenhydramine (Benadryl)September 24, 2020
			Dental amalgam
			FDA provides recommendations about the use of dental amalgam in certain high-risk populationsSeptember 23, 2020
			Metformin hydrochloride (Riomet ER)
			FDA reports that Sun Pharmaceutical Industries, Inc. is issuing a voluntary nationwide recall of RIOMET ERTM (Metformin Hydrochloride for Extended-Release Oral Suspension) due to N-nitrosodimethylamine content above the acceptable daily intake limitSeptember 23, 2020
			Benzodiazepines
			FDA requires Boxed Warning updated to improve safe use of benzodiazepine drug classAugust 27, 2020
			Hand sanitizers
			FDA updates on hand sanitizers consumers should not useJuly 23, 2020
			Naloxone
			FDA recommends health care professionals discuss naloxone with all patients when prescribing opioid pain relievers or medicines to treat opioid use disorderJuly 2, 2020
			Hand sanitizers contaminated with methanol
			FDA warns consumers of risk of methanol contamination in certain hand sanitizersJune 19, 2020
			Hand sanitizers contaminated with methanol
			FDA advises consumers not to use any hand sanitizer manufactured by Eskbiochem SA de CV in Mexico, due to the potential presence of methanol (wood alcohol)March 10, 2020
			HiRes Ultra and Ultra 30 cochlear implant devices
			FDA reports that Advanced Bionics will voluntarily initiate a field corrective action related to the initial version of HiRes Ultra and Ultra 30 cochlear implant devices due to a decrease in performance experienced by a small percentage of recipientsMarch 4, 2020
			Montelukast (Singulair)
			FDA requires Boxed Warning about serious mental health side effects for asthma and allergy drug montelukast (Singulair); advises restricting use for allergic rhinitisFebruary 27, 2020
			Ozone and ultraviolet (UV) light products for cleaning continuous positive airway pressure (CPAP) devices and accessories
			FDA reports potential risks associated with the use of unauthorized ozone and ultraviolet (UV) light products for cleaning CPAP machines and accessories (no ozone/UV cleaning products are currently approved)December 19, 2019
			Gabapentin (Neurontin, Gralise, Horizant) or pregabalin (Lyrica, Lyrica CR)
			FDA warns about serious breathing problems for patients with respiratory risk factors taking seizure and nerve pain medicines gabapentin (Neurontin, Gralise, Horizant) and pregabalin (Lyrica, Lyrica CR)November 5, 2019
			Biotin
			FDA warns that biotin may interfere with lab tests: update to 2017 Safety CommunicationAugust 30, 2019
			E-cigarette products
			FDA warns of incidents of severe respiratory disease associated with use of an e-cigarette productAugust 28, 2019
			Mavyret, Zepatier, Vosevi
			FDA warns about rare occurrence of serious liver injury with use of hepatitis C medicines Mavyret, Zepatier, and Vosevi in some patients with advanced liver diseaseJune 27, 2019
			Certain Medtronic MiniMedTM insulin pumps
			FDA warns about potential cybersecurity vulnerabilities affecting certain Medtronic MiniMed insulin pumpsJune 7, 2019
			Flavored e-liquid products
			FDA, FTC take action to protect kids by citing four firms that make, sell flavored e-liquids for violations related to online posts by social media influencers on their behalfJune 7, 2019
			Bobbie Baby Inc. infant formula
			FDA advises consumers to stop using infant formula from Bobbie Baby IncMay 17, 2019
			Continuous glucose monitoring systems (CGMs), insulin pumps, or automated insulin dosing (AID) systems
			FDA warns people with diabetes and health care providers against the use of devices for diabetes management not authorized for sale in the United StatesMay 7, 2019
			Medtronic pacemaker or cardiac resynchronization therapy pacemaker (CRT-P)
			FDA alerts providers and patients to check for premature battery depletion in certain Medtronic pacemakersApril 10, 2019
			Medical devices for concussion diagnosis, treatment, or management without FDA approval or clearance
			FDA recommends only using cleared or approved medical devices to help assess or diagnose a head injury, including concussionApril 9, 2019
			Opioid pain medicines
			FDA identifies harm reported from sudden discontinuation of opioid pain medicines and requires label changes to guide prescribers on gradual, individualized taperingApril 8, 2019
			Previously owned test strips
			FDA warns against use of previously owned test strips or test strips not authorized for sale in the United StatesMarch 21, 2019
			Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors
			FDA warns about cybersecurity vulnerabilities affecting Medtronic implantable cardiac devices, programmers, and home monitorsMarch 20, 2019
			DGTM/health NATURALS baby Cough Syrup + Mucus
			FDA posts Kingston Pharma, LLC recall of " DGTM/health NATURALS baby Cough Syrup + Mucus” as a public service because of possible health riskMarch 6, 2019
			Zoll LifeVest 4000 Wearable Cardioverter Defibrillator
			FDA updates warning on Zoll LifeVest 4000 Wearable Cardioverter Defibrillator - software update for potential lack of treatment (shock) delivery due to device failureDecember 20, 2018
			Teething jewelry (includes necklaces, bracelets and other jewelry)
			FDA warns against use of teething necklaces, bracelets, and other jewelry marketed for relieving teething pain or providing sensory stimulationDecember 20, 2018
			Fluoroquinolone antibiotics
			FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patientsNovember 20, 2018
			Gilenya (fingolomid)
			FDA warns about severe worsening of multiple sclerosis after stopping the medicine Gilenya (fingolimod)November 16, 2018
			Honey pacifiers
			FDA reports that honey pacifiers are suspected in Texas infant botulism casesNovember 15, 2018
			Flavored tobacco products, menthol in cigarettes
			FDA Commissioner Scott Gottlieb, M.D., issues a statement on proposed new steps to protect youth by preventing access to flavored tobacco products and banning menthol in cigarettesNovember 1, 2018
			Genetic laboratory tests claiming to predict response to specific medications
			FDA warns against the use of many genetic tests with unapproved claims to predict patient response to specific medicationsSeptember 12, 2018
			E-cigarettes
			FDA takes new steps to address epidemic of youth e-cigarette use, including a historic action against more than 1,300 retailers and 5 major manufacturers for their roles perpetuating youth accessAugust 3, 2018
			Zithromax, Zmax (azithromycin)
			FDA warns about increased risk of cancer relapse with long-term use of azithromycin (Zithromax, Zmax) antibiotic after donor stem cell transplantJuly 10, 2018
			Fluoroquinolone antibiotics
			FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changesMay 23, 2018
			Over-the-counter (OTC) oral drug products containing benzocaine
			FDA warns about oral over-the-counter benzocaine products used for teething and mouth pain and prescription local anesthetics because of risk of serious and potentially fatal blood disorder.May 18, 2018
			Products containing dolutegravir (Juluca, Tivicay, Triumeq)
			FDA evaluates potential risk of neural tube birth defects with HIV medicine dolutegravir (Juluca, Tivicay, Triumeq)Apr. 25, 2018
			Lamictal (lamotrigine)
			FDA warns of serious immune system reaction with seizure and mental health medicine lamotrigine (Lamictal).February 22, 2018
			Biaxin (clarithromycin)
			FDA review finds additional data supports the potential for increased long-term risks with antibiotic clarithromycin (Biaxin) in patients with heart disease.January 30, 2018
			Over-the counter (OTC) anti-diarrhea drug loperamide
			FDA limits packaging for anti-diarrhea medicine loperamide (Imodium) to encourage safe use.January 11, 2018
			Prescription cough and cold medicines containing codeine or hydrocodone
			FDA requires labeling changes for prescription opioid cough and cold medicines to limit their use to adults 18 years and older.December 20, 2017
			Long-acting beta agonists (LABAs)
			FDA 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 19, 2017
			Gadolinium-based contrast agents (GBCAs)
			FDA warns that gadolinium-based contrast agents (GBCAs) are retained in the body; requires new class warningsMay 22, 2017
			Gadolinium-based contrast agents (GBCAs)
			FDA identifies no harmful effects to date with brain retention of gadolinium-based contrast agents for MRIs; review to continuePlease refer to the updated Drug Safety Communication for GBCAs dated December 19, 2017Apr. 27, 2017
			General Anesthetic and Sedation Drugs
			FDA approves label changes for use of general anesthetic and sedation drugs in young childrenApr. 20, 2017
			Codeine and tramadol containing products
			FDA restricts use of prescription codeine pain and cough medicines and tramadol pain medicines in children; recommends against use in breastfeeding womenJan. 27, 2017
			Hyland's belladonna-containing homeopathic teething products
			FDA confirms elevated levels of belladonna in certain homeopathic teething products.Dec. 14, 2016
			General anesthetics and sedation drugs
			FDA review results in new warnings about using general anesthetics and sedation drugs in young children and pregnant womenAug. 31, 2016
			The combination of opioid pain or cough medicines with benzodiazepines
			FDA warns about serious risks and death when combining opioid pain or cough medicines with benzodiazepines; requires its strongest warningJuly 26, 2016
			Oral and injectable flouroquinolone antibiotics
			FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effectsJune 7, 2016
			Imodium (loperamide)
			FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuseJune 6, 2016
			Over-the-counter antacid products containing aspirin (such as Alka-Seltzer Original, Bromo Seltzer, Medique Medi Seltzer, Picot Plus Effervescent, Vida Mia Pain Relief, Winco Foods Effervescent Antacid and Pain Relief, and Zee-Seltzer Antacid and Pain Reliever)
			FDA warns about serious bleeding risk with over-the-counter antacid products containing aspirinMay 12, 2016
			Flouroquinolone antibiotics
			FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur togetherMay 10, 2016
			Zyprexa, Zyprexa Zydis, Zyprexa Relprevy, Symbyax (olanzapine)
			FDA warns about rare but serious skin reactions with mental health drug olanzapine (Zyprexa, Zyprexa Zydis, Zyprexa Relprevv, and Symbyax)May 3, 2016
			Abilify, Abilify Maintena, Aristada (aripprazole)
			FDA warns about new impulse-control problems associated with mental health drug aripiprazole (Abilify, Abilify Maintena, Aristada)April 8, 2016
			Metformin
			FDA revises warnings regarding use of the diabetes medicine metformin in certain patients with reduced kidney functionMarch 22, 2016
			Opioid pain medicines
			FDA warns about several safety issues with opioid pain medicines; requires label changesJan. 4, 2016
			Noxafil (posaconazole)
			FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approvedNov. 17, 2015
			Iodine-containing Contrast Agents (Cystografin, MD-76R,Cholografin Meglumine,Visipaque, Omnipaque, Isovue,Ultravist, Conray, Optiray,Hexabrix, Oxilan)
			FDA advises of rare cases of underactive thyroid in infants given iodine-containing contrast agents for medical imagingSept. 21, 2015
			Ultram, Ultram ER, Conzip, and generics (tramadol)
			FDA evaluates the risks of using the pain medicine tramadol in children aged 17 and youngerJuly 16, 2015
			Proglycem (diazoxide)
			FDA warns about a serious lung condition in infants and newborns treated with Proglycem (diazoxide)July 1, 2015
			Codeine cough and cold medicines
			FDA evaluates the potential risks of using codeine cough-and-cold medicines in childrenJune 26, 2014
			Oral viscous lidocaine 2% solution
			FDA recommends not using lidocaine to treat teething pain and requires new Boxed WarningJune 25, 2014
			Over- the-counter acne products (such as Proactiv, Neutrogena, MaxClarity, Oxy, Ambi, Aveeno, Clean&Clear, and as store brands)
			FDA warns of rare but serious hypersensitivity reactions with certain over-the-counter topical acne productsMar. 31, 2014
			Revatio (sildenafil)
			FDA clarifies warning about pediatric use of Revatio (sildenafil) for pulmonary arterial hypertensionDec. 17, 2013
			Concerta (methylphenidate hydrochloride), Daytrana (methylphenidate), Focalin and Focalin XR (dexmethylphenidate hydrochloride), Metadate CD and Metadate ER (methylphenidate hydrochloride), Methylin and Methylin ER (methylphenidate hydrochloride), Quillivant XR (methylphenidate hydrochloride), Ritalin, Ritalin LA, and Ritalin SR (methylphenidate hydrochloride)
			FDA warns of rare risk of long-lasting erections in males taking methylphenidate ADHD medications and has approved label changes.Feb. 26, 2013
			Sensipar (cinacalcet hydrochloride)
			FDA suspends clinical studies of Sensipar (cinacalcet hydrochloride) after report of deathFeb. 20, 2013
			Codeine and Codeine-Containing Products
			FDA updates safety review of codeine use in children; new Boxed Warning and Contraindication on use after tonsillectomy and/or adenoidectomy.Oct. 25, 2012
			Over the-counter tetrahydrozoline, oxymetazoline, or naphazoline containing eye drops and nasal decongestant sprays
			FDA reports serious adverse events from accidental ingestion by children of over-the-counter eye drops and nasal spraysAug. 30, 2012
			Revatio (silfenadil)
			FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertensionAug. 15, 2012
			Codeine and Codeine-Containing Products
			FDA warns that codeine use in certain children after tonsillectomy and/or adenoidectomy may lead to rare, but life-threatening adverse events or deathJune 29, 2012
			Zofran (ondansetron)
			FDA reports new information regarding QT prolongation with ondansetron (Zofran)Dec. 22, 2011
			Acetaminophen
			FDA informs the public of another concentration of liquid acetaminophen marketed for infantsDec. 14, 2011
			Celexa (citalopram); Lexapro (escitalopram); Prozac, Sarafem, Symbyax (fluoxetine); Luvox, Luvox CR (fluvoxamine); Paxil, Paxil CR, Pexeva (paroxetine); Zoloft (sertraline); Viibryd (vilazodone)
			FDA reports the potential risk of a rare heart and lung condition in newborn babies associated with the use of selective serotonin reuptake inhibitor (SSRI) antidepressants by women during pregnancyNov. 3, 2011
			Tumor necrosis factor (TNF) blockers [Remicade (infliximab), Enbrel (etanercept), Humira (adalimumab), Cimzia (certolizumab pegol) and Simponi (golimumab)
			FDA provides a safety update Tumor Necrosis Factor (TNF) blockers and the risk for pediatric malignancyNov. 1, 2011
			Concerta, Daytrana, Metadate CD, Metadate ER, Methylin, Methylin ER, Ritalin, Ritalin-LA, Ritalin-SR (methylphenidate), Focalin, Focalin XR (dexmethylphenidate), Dexedrine, Dexedrine Spansules, Dextroamphetamine ER, Dextrostate (dextroamphetamine sulfate), Vyvanse (lisdexamfetamine dimesylate), Adderall, Adderall XR (amphetamine, mixed salts), Desoxyn (methamphetamine), Cylert- no longer marketed (pemoline), Strattera (atomoxetine)
			FDA provides a safety update of medications used to treat Attention-Deficit/Hyperactivity Disorder (ADHD) in children and young adultsSep. 15, 2011
			Zofran (ondansetron)
			FDA reports abnormal heart rhythms may be associated with use of Zofran (ondansetron)Aug. 4, 2011
			Recombinant Human Growth Hormone (somatropin)
			FDA provides a safety update of Recombinant Human Growth Hormone (somatropin) and possible increased risk of deathJuly 11, 2011
			Tamiflu (oseltamivir phosphate) for Oral Suspension
			FDA reports important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspensionJune 30, 2011
			Valproate sodium, valproic acid, divalproex sodium
			FDA reports that children born to mothers who took Valproate products while pregnant may have impaired cognitive developmentMay 20, 2011
			SimplyThick
			FDA warns healthcare professionals and the public not to feed SimplyThick to infants born before 37 weeks gestation because of the risk of necrotizing enterocolitis (NEC)April 15, 2011
			Long-acting beta agonists (LABAs): Symbicort (budesonide and formoterol), Advair Diskus (fluticasone and salmeterol), Dulera (mometasone and formoterol), Foradil, Foradil with fluticasone (formoterol)
			FDA requires post-market safety trials for Long-Acting Beta-Agonists (LABAs)Mar. 8, 2011
			Kaletra (lopinavir/ritonavir)
			FDA warns of serious health problems seen in premature babies given Kaletra (lopinavir/ritonavir) oral solutionFeb. 22, 2011
			Antipsychotic drugs
			FDA updates antipsychotic drug labels on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newbornsJan. 12, 2011
			Lantus (insulin glargine)
			FDA provides an update to an ongoing safety review of Lantus (insulin glargine) and possible risk of cancerDec. 14, 2010
			Tessalon (benzonatate)
			FDA reports a death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of ageSep. 15, 2010
			Valcyte (valganciclovir hydrochloride)
			FDA provides new dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patientsAug. 12, 2010
			Lamictal (lamotrigine)
			FDA reports aseptic meningitis associated with use of Lamictal (lamotrigine)July 29, 2010
			Evamist (estradiol transdermal spray)
			FDA reports an ongoing safety review of Evamist (estradiol transdermal spray) and unintended Ongoing exposure of children and pets to topical estrogenJune 15, 2010
			Vitamin D Supplement Products
			FDA reports infant overdose risk with liquid Vitamin DJune 2, 2010
			Serevent Diskus (Salmeterol); Foradil Aerolizer (Formoterol); Foradil Certihaler* (Formoterol); Advair Diskus (Salmeterol/Fluticasone); Advair HFA (Salmeterol/Fluticasone); Symbiort (Formoterol/Budesonide); Brovana (Arformoterol); Perforomist (Formoterol)
			FDA reports that drug labels now contain updated recommendations on the appropriate use of long-acting inhaled asthma medications called Long-Acting Beta-Agonists (LABAs)/node/390709

* Not currently marketed in the U.S.

                                                                                  Content current as of:
      01/16/2024Pediatrics

          
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