| March 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 rhinitis |
| February 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 Communication |
| August 30, 2019 |
E-cigarette products |
FDA warns of incidents of severe respiratory disease associated with use of an e-cigarette product |
| August 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 disease
|
| June 27, 2019 |
Certain Medtronic MiniMed™ insulin pumps |
FDA warns about potential cybersecurity vulnerabilities affecting certain Medtronic MiniMed insulin pumps |
| June 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 behalf |
| June 7, 2019 |
Bobbie Baby Inc. infant formula |
FDA advises consumers to stop using infant formula from Bobbie Baby Inc |
| May 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 States |
| May 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 pacemakers |
| April 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 concussion |
| April 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 tapering |
| April 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 States |
| March 21, 2019 |
Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors |
FDA warns about cybersecurity vulnerabilities affecting Medtronic implantable cardiac devices, programmers, and home monitors |
| March 20, 2019 |
DG™/health NATURALS baby Cough Syrup + Mucus |
FDA posts Kingston Pharma, LLC recall of " DG™/health NATURALS baby Cough Syrup + Mucus” as a public service because of possible health risk |
| March 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 failure |
| December 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 stimulation |
| December 20, 2018 |
Fluoroquinolone antibiotics |
FDA warns about increased risk of ruptures or tears in the aorta blood vessel with fluoroquinolone antibiotics in certain patients |
| November 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 cases |
| November 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 cigarettes |
| November 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 medications |
| September 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 access |
| August 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 transplant |
| July 10, 2018 |
Fluoroquinolone antibiotics |
FDA reinforces safety information about serious low blood sugar levels and mental health side effects with fluoroquinolone antibiotics; requires label changes |
| May 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 warnings |
| May 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 continue
Please refer to the updated Drug Safety Communication for GBCAs dated December 19, 2017 |
| Apr. 27, 2017 |
General Anesthetic and Sedation Drugs |
FDA approves label changes for use of general anesthetic and sedation drugs in young children |
| Apr. 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 women |
| Jan. 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 women |
| Aug. 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 warning |
| July 26, 2016 |
Oral and injectable flouroquinolone antibiotics |
FDA updates warnings for oral and injectable fluoroquinolone antibiotics due to disabling side effects |
| June 7, 2016 |
Imodium (loperamide) |
FDA warns about serious heart problems with high doses of the antidiarrheal medicine loperamide (Imodium), including from abuse and misuse |
| June 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 aspirin |
| May 12, 2016 |
Flouroquinolone antibiotics |
FDA advises restricting fluoroquinolone antibiotic use for certain uncomplicated infections; warns about disabling side effects that can occur together |
| May 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 function |
| March 22, 2016 |
Opioid pain medicines |
FDA warns about several safety issues with opioid pain medicines; requires label changes |
| Jan. 4, 2016 |
Noxafil (posaconazole) |
FDA cautions about dosing errors when switching between different oral formulations of antifungal Noxafil (posaconazole); label changes approved |
| Nov. 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 imaging |
| Sept. 21, 2015 |
Ultram, Ultram ER, Conzip, and generics (tramadol) |
FDA evaluates the risks of using the pain medicine tramadol in children aged 17 and younger |
| July 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 children |
| June 26, 2014 |
Oral viscous lidocaine 2% solution |
FDA recommends not using lidocaine to treat teething pain and requires new Boxed Warning |
| June 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 products |
| Mar. 31, 2014 |
Revatio (sildenafil) |
FDA clarifies warning about pediatric use of Revatio (sildenafil) for pulmonary arterial hypertension |
| Dec. 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 death |
| Feb. 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 sprays |
| Aug. 30, 2012 |
Revatio (silfenadil) |
FDA recommends against use of Revatio (sildenafil) in children with pulmonary hypertension |
| Aug. 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 death |
| June 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 infants |
| Dec. 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 pregnancy |
| Nov. 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 malignancy |
| Nov. 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 adults |
| Sep. 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 death |
| July 11, 2011 |
Tamiflu (oseltamivir phosphate) for Oral Suspension |
FDA reports important safety changes to the influenza drug Tamiflu (oseltamivir phosphate) for oral suspension |
| June 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 development |
| May 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 solution |
| Feb. 22, 2011 |
Antipsychotic drugs |
FDA updates antipsychotic drug labels on use during pregnancy and risk of abnormal muscle movements and withdrawal symptoms in newborns |
| Jan. 12, 2011 |
Lantus (insulin glargine) |
FDA provides an update to an ongoing safety review of Lantus (insulin glargine) and possible risk of cancer |
| Dec. 14, 2010 |
Tessalon (benzonatate) |
FDA reports a death resulting from overdose after accidental ingestion of Tessalon (benzonatate) by children under 10 years of age |
| Sep. 15, 2010 |
Valcyte (valganciclovir hydrochloride) |
FDA provides new dosing recommendations to prevent potential Valcyte (valganciclovir) overdose in pediatric transplant patients |
| Aug. 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 estrogen |
| June 15, 2010 |
Vitamin D Supplement Products |
FDA reports infant overdose risk with liquid Vitamin D |
| June 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) |
