July – September 2020 | Potential Signals of Serious Risks/New Safety

Actemra (tocilizumab)

 

Hepatitis B reactivation

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

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

The “Adverse Reactions” section of the labeling was updated in April 2021 to include nail psoriasis.

Example: Aubagio labeling

Aubagio (teriflunomide)

Generic products containing teriflunomide

Tooth disorder

FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.

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)

Darzalex Faspro (daratumumab, hyaluronidase-fihj)*

Ocular toxicity

 

 

The “Warnings and Precautions”, and “Patient Counseling Information” sections of the labeling were updated in January 2022 to include information about ocular toxicity.

Darzalex labeling

*An administrative error resulted in the omission of Darzalex Faspro from this signal and was added after the initial quarterly report was posted.

Entyvio (vedolizumab) Pancreatitis

The “Adverse Reactions” section of the labeling was updated in August 2021 to include pancreatitis.

Entyvio labeling

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 oral and intravenous* 

Helidac Therapy (bismuth subsalicylate, metronidazole, and tetracycline hydrochloride)**

Pylera (bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride)**

Generic products containing metronidazole (oral and intravenous)

Torsade de pointes/ QT prolongation

 

The “Precautions” and “Adverse Reactions” sections of the labeling for oral and intravenous metronidazole products were updated in March 2021 to include QT-prolongation.

Example: Pylera labeling

*Product names updated for clarity.

**An administrative error resulted in the omission of Helidac and Pylera from this signal and were added after the initial quarterly report was posted.

Otezla (apremilast)

Generic products containing apremilast

Hypersensitivity

The “Warnings and Precautions” and “Patient Counseling Information” sections of the labeling were updated in December 2021 to include information about hypersensitivity.

Example: Otezla labeling

Polidocanol (compounded drug) Product Compounding Quality

FDA determined that no action is necessary at this time based on available information. FDA is continuing to monitor this issue.

Proton Pump Inhibitors

• AcipHex (rabeprazole sodium)
• AcipHex Sprinkle (rabeprazole 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 determined that no action is necessary at this time based on available information. FDA is continuing to monitor this issue.

Rinvoq (upadacitinib)

 

Hypersensitivity

 

The “Warnings and Precautions” section of the labeling was updated in January 2022 to include information about hypersensitivity reactions.

Rinvoq labeling

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 sodium)

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)

 

The “Adverse Reactions” section of the labeling was updated between March 2021 and May 2021 to include acute myocardial ischemia with or without myocardial infarction that may occur as part of an allergic reaction.

Example: Zinacef labeling

Zyvox (linezolid)

Generic products containing linezolid

Inappropriate antidiuretic hormone secretion

The “Warnings and Precautions”, and “Adverse Reactions” sections of the labeling were updated in October 2021 to include inappropriate antidiuretic hormone secretion.

Example: Zyvox labeling

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