October – December 2023 | Potential Signals of Serious Risks/New Safet

Acetaminophen-containing products

 

Metabolic acidosis FDA is evaluating the need for regulatory action.

Certain adenosine injection (generic product)

Certain amiodarone hydrochloride injection (generic product)

Look alike container labels that contribute to wrong drug errors

The container label and carton labeling for certain adenosine products were revised in July 2024 to mitigate the potential for medication errors.

FDA has determined that the last approved labeling for certain amiodarone hydrochloride products is adequately labeled, and that no further regulatory action is needed at this time.

Alecensa (alectinib)

Xalkori (crizotinib)

Acute pancreatitis

FDA determined that no action was necessary at the time based on available information.  

Aplenzin (bupropion hydrobromide)

Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride)

Contrave (naltrexone hydrochloride and bupropion hydrochloride)

Forfivo XL (bupropion hydrochloride)

Wellbutrin (bupropion hydrochloride)

Wellbutrin SR (bupropion hydrochloride)

Wellbutrin XL (bupropion hydrochloride extended release)

Meningitis aseptic

The “Adverse Reactions” section of the labeling was updated in November 2025 to include aseptic meningitis.

Example: Wellbutrin SR labeling

Aplenzin (bupropion hydrobromide)

Auvelity (dextromethorphan hydrobromide and bupropion hydrochloride)

Contrave (naltrexone hydrochloride and bupropion hydrochloride)

Forfivo XL (bupropion hydrochloride)

Wellbutrin (bupropion hydrochloride)

Wellbutrin SR (bupropion hydrochloride)

Wellbutrin XL (bupropion hydrochloride extended release)

 

Brugada syndrome

The “Adverse Reactions” section of the labeling was updated between November 2023 and May 2024 to include Brugada pattern/syndrome.

Example: Contrave labeling

Beyfortus (nirsevimab-alip) Hypersensitivity

The “Warnings and Precautions” section of the labeling was updated in February 2024 to include risk of serious hypersensitivity reactions following Beyfortus administration.

Beyfortus labeling

 

Braftovi (encorafenib)

Zelboraf (vemurafenib)

Hemophagocytic lymphohistiocytosis

FDA determined that no action was necessary at the time based on available information.

Central Nervous System (CNS) stimulants Electrocardiogram QT prolonged

FDA determined that no action was necessary at the time based on available information.

Gilotrif (afatinib)

Iressa (gefitinib)

Tarceva (erlotinib)

Cardiac failure

FDA determined that no action was necessary at the time based on available information.

Gonadotropin releasing hormone (GnRH) agonists

• Fensolvi (leuprolide acetate)
• Lupron Depot (leuprolide acetate for depot suspension)
• Lupron Depot-Ped (leuprolide acetate for depot suspension)
• Lupaneta Pack (leuprolide acetate for depot suspension, for injection; norethindrone acetate tablets)
• Supprelin LA (histrelin acetate)
• Synarel (nafarelin acetate)
• Triptodur (triptorelin)

Severe cutaneous adverse reactions

The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” or “Patient Instructions for Use” sections of the labeling were updated in November 2025 to include severe cutaneous adverse reactions.

Example: Fensolvi labeling

Imcivree (setmelanotide) Hypersensitivity

The “Contraindications”, “Warnings and Precautions”, and “Postmarketing Experience” sections of the labeling were updated in November 2023 to include hypersensitivity reactions.

Imcivree labeling

 

Liptruzet (ezetimibe and atorvastatin)

Nexlizet (bempedoic acid and ezetimibe)

Roszet (rosuvastatin and ezetimibe)

Vytorin (ezetimibe and simvastatin)

Zetia (ezetimibe)

Drug-induced liver injury

The “Adverse Reactions” section of the labeling was updated between February 2024 and October 2024 to include information about drug-induced liver injury.
Example: Zetia Labeling

Liptruzet (ezetimibe and atorvastatin)

Nexlizet (bempedoic acid and ezetimibe)

Roszet (rosuvastatin and ezetimibe)

Vytorin (ezetimibe and simvastatin)

Zetia (ezetimibe)

Severe cutaneous adverse reaction FDA decided that no action is necessary at this time based on available information. Lupkynis (voclosporin) Hypersensitivity

The “Contraindications”, “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in October 2025 to include information about hypersensitivity.

Lupkynis labeling

Systemic (oral/intravenous) metronidazole-containing products Hearing impairment

The “Adverse Reactions” section of the labeling was updated in July 2024 to include hearing impairment.

Example: Metronidazole labeling
 

Oncaspar (pegaspargase)

Rylaze (asparaginase erwinia chrysanthemi (recombinant)- rywn)

Veno-occlusive liver disease

The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated between March 2024 and April 2024 to include information about veno-occlusive liver disease.

Example: Oncaspar labeling 
 

Rybrevant (amivantamab-vmjw) Anaphylactic reaction

The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in February 2025 to include information about anaphylactic reactions.

Rybrevant labeling

Sphingosine 1-phosphate receptor (S1PR) modulators

• Mayzent (siponimod)
• Ponvory (ponesimod)
• Velsipity (etrasimod)
• Zeposia (ozanimod)

Drug-induced liver injury

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” and “Medication Guide” sections of the labeling for Zeposia were updated in August 2024 to include information about the risk of clinically significant liver injury.

Zeposia Labeling

FDA determined that no action is necessary at the time for the other products based on available information.

Turalio (pexidartinib) Posterior reversible encephalopathy syndrome

FDA determined that no action was necessary at the time based on available information. 
 

Veozah (fezolinetant) Drug-induced liver injury

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Patient Information” sections of the labeling were updated in August 2024 to include information about drug-induced liver injury.

Veozah labeling

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