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  5. FDA's Adverse Event Reporting System (FAERS)
  6. July - September 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. FDA's Adverse Event Reporting System (FAERS)

July - September 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

 

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of January 14, 2021)

Actemra (tocilizumab)

 

Hepatitis B reactivation

FDA is evaluating the need for regulatory action.

Alcohol containing hand sanitizers

 

Blood methanol induced blindness and death

Regulatory actions taken.

For additional details, refer to: www.fda.gov/handsanitizerlist   

 

Aubagio (teriflunomide)

Generic products containing teriflunomide

Nail disorder

FDA is evaluating the need for regulatory action.

Aubagio (teriflunomide)

Generic products containing teriflunomide

Tooth disorder

FDA is evaluating the need for regulatory action.

Benadryl (diphenhydramine)

Generic products containing diphenhydramine hydrochloride

 

Drug abuse and dependence

FDA decided that no action is necessary at this time based on available information.

FDA Drug Safety Communication (9/24/2020)

 

Bosulif (bosutinib monohydrate)

Gleevec (imatinib mesylate)

Generic drugs containing imatinib mesylate

Facial paralysis

FDA decided that no action is necessary at this time based on available information.

Cyklokapron (tranexamic acid) injection

Generic products containing tranexamic acid

Wrong route of administration error (inadvertent intrathecal administration instead of recommended intravenous administration)

The prescribing information was updated to include the risk of medication errors due to incorrect route of administration.  The carton and container labeling was also revised to highlight the recommended intravenous route of administration.

FDA Safety Communication to Healthcare Providers (12/3/2020)

 

Darzalex (daratumumab)

Ocular toxicity

 

 

FDA is evaluating the need for regulatory action.

Entyvio (vedolizumab)

Pancreatitis

FDA is evaluating the need for regulatory action.

Finasteride Plus 1.25mg capsules (compounded drug)

 

Minoxidil (compounded drug)

Cardiac effects related to undeclared or higher than labeled dose of minoxidil that include tachycardia, low blood pressure, and salt and water retention causing swelling

Voluntary recall

Metronidazole

Metronidazole benzoate

Metronidazole hydrochloride

Metronidazole hydrocholride C-14

Metronidazole phosphate

Generic products containing metronidazole

Torsade de pointes/ QT prolongation

 

FDA is evaluating the need for regulatory action.

Otezla (apremilast)

Generic products containing apremilast

Hypersensitivity

FDA is evaluating the need for regulatory action.

Polidocanol (compounded drug)

Product Compounding Quality

FDA is evaluating the need for regulatory action.

Proton Pump Inhibitors

  • AcipHex (raberprazole sodium)
  • AcipHex Sprinkle (raberprazole sodium)
  • Dexilant (dexlansoprazole)
  • Nexium (esomeprazole)
  • Nexium 24 HR (esomeprazole magnesium)
  • Nexium IV (esomeprazole sodium) 
  • Omeclamox-Pak (omeprazole, clarithromycin, amoxicillin)
  • Prevacid (lansoprazole)
  • Prevacid 24 HR (lansoprazole)
  • Prevacid SoluTab (lansoprazole)
  • Prilosec (omeprazole)
  • Prilosec OTC (omeprazole magnesium)  
  • Protonix (pantoprazole)
  • Protonix IV (pantoprazole sodium)
  • Talicia (omeprazole magnesium, amoxicillin, ribafutin)
  • Vimovo (esomeprazole magnesium and naproxen)
  • Yosprala (aspirin and omeprazole)
  • Zegerid (omeprazole and sodium bicarbonate)
  • Zegerid OTC (omeprazole and sodium bicarbonate)
  • Generic products containing proton pump inhibitors

Rhabdomyolysis

FDA is evaluating the need for regulatory action.

Rinvoq (upadacitinib)

 

Hypersensitivity

 

FDA is evaluating the need for regulatory action.

Teflaro (ceftaroline fosamil)

 

Neurotoxicity

The “Warnings and Precautions,” “Adverse Reactions” and “Patient Counseling Information” sections of the labeling for Teflaro were updated November 2020 to include neurological adverse reactions.

Teflaro labeling

 

Testosterone Pellets (compounded drug)

Breast Cancer

FDA decided that no action is necessary at this time based on available information.

Zinacef (cefuroxime)

Ceftin (cefuroxime axetil)

Generic products containing cefuroxime

Kounis syndrome (Acute myocardial ischemia with or without myocardial infarction that may occur as part of an allergic reaction)

 

FDA is evaluating the need for regulatory action.

Zyvox (linezolid)

Generic products containing linezolid

Inappropriate antidiuretic hormone secretion

FDA is evaluating the need for regulatory action.
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