July – September 2023 | Potential Signals of Serious Risks/New Safety

Allergenic Extract – Peanut (Arachis hypogaea) – For Diagnostic Use Only, manufactured by ALK-Abelló, Inc. Certain product lots were associated with increased reports of false negative skin test results, with some cases of anaphylaxis from subsequent peanut exposure.

The Package Insert – Allergenic Extracts was revised in February 2023 to include a Warning for Anaphylaxis Following False Negative Food Allergen Skin Test Results.

All Allergenic Extracts for Diagnosis of Food Allergy: FDA Safety Communication – FDA Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in the Prescribing Information

Amoxil (amoxicillin)

Augmentin (amoxicillin and clavulanate potassium)

Augmentin ES-600 (amoxicillin and clavulanate potassium)

Augmentin XR (amoxicillin and clavulanate potassium)

Moxatag (amoxicillin extended-release tablets)

Omeclamox-Pak (omeprazole delayed-release capsules; clarithromycin tablets; amoxicillin capsules)

Talicia (omeprazole magnesium, amoxicillin and rifabutin delayed-release capsules)

Voquezna Dual Pak (vonoprazan tablets; amoxicillin capsules)

Voquezna Triple Pak (vonoprazan tablets; amoxicillin capsules; clarithromycin tablets)

Drug-Induced Enterocolitis Syndrome

The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in May 2024 to include information about drug-induced enterocolitis syndrome (DIES).

Example: Amoxil labeling

Bactrim (sulfamethoxazole and trimethoprim)

Bactrim DS (sulfamethoxazole and trimethoprim)

Septra (sulfamethoxazole and trimethoprim)

Septra DS (sulfamethoxazole and trimethoprim)

Sulfatrim (sulfamethoxazole and trimethoprim)

Sulfamethoxazole and Trimethoprim

 

Hemophagocytic lymphohistiocytosis

The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated in February 2025 to include information about hemophagocytic lymphohistiocytosis (HLH).

Example: Sulfatrim labeling

BCMA- or CD19-directed genetically modified autologous T-cell immunotherapies

• Abecma (idecabtagene vicleucel)
• Breyanzi (lisocabtagene maraleucel)
• Carvykti (ciltacabtagene autoleucel)
• Kymriah (tisagenlecleucel)
• Tecartus (brexucabtagene autoleucel)
• Yescarta (axicabtagene ciloleucel)

Post-treatment T-cell malignancy

FDA issued a Safety Communication on April 18, 2024: FDA Requires Boxed Warning for T cell Malignancies Following Treatment with BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies.

The Boxed Warning was updated and related changes were made to other sections of the labels (Warnings and Precautions, Postmarketing Experience, Patient Counseling Information and Medication Guide) to include the serious risk of T cell malignancies following treatment with BCMA-directed or CD19-directed autologous chimeric antigen receptor (CAR) T cell immunotherapies as class safety labeling changes:

Cabometyx (cabozantinib)

Cometriq (cabozantinib)

Rhabdomyolysis

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

Elepsia XR (levetiracetam)

Keppra (levetiracetam)

Keppra XR (levetiracetam)

Levetiracetam in Sodium Chloride

Spritam (levetiracetam)

Drug reaction with eosinophilia and systemic symptoms

An FDA Drug Safety Communication was issued on November 28, 2023. The FDA is requiring applicants of these medicines to add new warnings about drug reaction with eosinophilia and systemic symptoms to the prescribing information and the Medication Guide for patients and caregivers.

FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan)

 

Gemcitabine

Infugem (gemcitabine in sodium chloride injection)

Drug reaction with eosinophilia and systemic symptoms

The “Dosage and Administration”, “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated between May 2024 and September 2024 to include information about Severe Cutaneous Adverse Reactions (SCARs).

Example: Gemcitabine labeling

Gilenya (fingolimod)

Mayzent (siponimod)

Ponvory (ponesimod)

Tascenso ODT (fingolimod)

Zeposia (ozanimod)

 

Progressive multifocal leukoencephalopathy

The “Warnings and Precautions” section of the labeling was updated in June 2024 to include information about progressive multifocal leukoencephalopathy (PML).

Example: Tascenso ODT labeling

FDA required a postmarketing requirement (PMR) study in December 2024 for sphingosine 1-phosphate (S1P) receptor modulators  to assess risk factors for the development of PML among patients with multiple sclerosis exposed to  S1P receptor modulators. Potential risk factors to be assessed include age, duration of exposure to the therapy, prior immunosuppressant use, lymphopenia, and anti-JCV antibody status.

Glucagon-like peptide-1 (GLP-1) receptor agonists

• Adlyxin (lixisenatide)
• Byetta (exenatide)
• Bydureon (exenatide)
• Bydureon BCise (exenatide)
• Mounjaro (tirzepatide)
• Ozempic (semaglutide)
• Rybelsus (semaglutide)
• Saxenda (liraglutide)
• Soliqua 100/33 (insulin glargine and lixisenatide)
• Trulicity (dulaglutide)
• Victoza (liraglutide)
• Wegovy (semaglutide)
• Xultophy 100/3.6 (insulin degludec and liraglutide)

 

Alopecia

The “Adverse Reactions” section of the labeling for Adlyxin, Saxenda, Soliqua 100/33, Trulicity, Victoza, Mounjaro, Ozempic, Rybelsus, and Xultophy 100/3.6 was updated between December 2024 and May 2025 to include alopecia.

Example: Xultophy 100/3.6 labeling

FDA has determined that the last approved labeling is adequate for Byetta, Bydureon, Bydureon BCise, Wegovy, and Zepbound and that no further regulatory action is needed at the time.

*An administrative error resulted in the omission of Zepbound from the list of product names and was added after the initial quarterly report was posted. 

Glucagon-like peptide-1 (GLP-1) receptor agonists

• Adlyxin (lixisenatide)
• Byetta (exenatide)
• Bydureon (exenatide)
• Bydureon BCise(exenatide)
• Mounjaro (tirzepatide)
• Ozempic (semaglutide)
• Rybelsus (semaglutide)
• Saxenda (liraglutide)
• Soliqua 100/33 (insulin glargine and lixisenatide)
• Trulicity (dulaglutide)
• Victoza (liraglutide)
• Wegovy (semaglutide)
• Xultophy 100/3.6 (insulin degludec and liraglutide)
• Zepbound (tirzepatide)

 

Aspiration

The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated between October 2024 and November 2024 to include information about aspiration during general anesthesia or deep sedation.

Example: Adlyxin labeling

FDA required a postmarketing requirement (PMR) trial in November 2024 to measure the effects of temporary withholding of GLP-1 receptor agonists and fasting duration on retained gastric contents to evaluate delayed gastric emptying  associated with GLP-1 receptor agonist use and inform potential recommendations to mitigate the serious risk of pulmonary aspiration. 

Glucagon-like peptide-1 (GLP-1) receptor agonists

• Adlyxin (lixisenatide)
• Byetta (exenatide)
• Bydureon (exenatide)
• Bydureon BCise (exenatide)
• Mounjaro (tirzepatide)
• Ozempic (semaglutide)
• Rybelsus (semaglutide)
• Saxenda (liraglutide)
• Soliqua 100/33 (insulin glargine and lixisenatide)
• Trulicity (dulaglutide)
• Victoza (liraglutide)
• Wegovy (semaglutide)
• Xultophy 100/3.6 (insulin degludec and liraglutide)
• Zepbound (tirzepatide)

 

Suicidal ideation FDA is evaluating the need for regulatory action.

Kyprolis (carfilzomib)

Ninlaro (ixazomib)

Anaphylactic reaction

The “Adverse Reactions” and “Patient Information” sections of the labeling for Ninlaro were updated in July 2024 to include information about angioedema.

Ninlaro labeling

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

Lupkynis (voclosporin)

 

Nausea and vomiting symptoms

The “Adverse Reactions” section of the labeling was updated in October 2025 to include nausea and vomiting.

Lupkynis labeling

Ocrevus (ocrelizumab) Drug-induced liver injury

    
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and “Medication Guide” sections of the labeling were updated in August 2025 to include information about clinically significant liver injury, without findings of viral hepatitis, in patients treated with ocrelizumab and other anti-CD20 monoclonal antibodies approved for the treatment of multiple sclerosis (including Kesimpta and Briumvi). 

Ocrevus labeling 

Onfi (clobazam)

Sympazan (clobazam)

 

Drug reaction with eosinophilia and systemic symptoms

An FDA Drug Safety Communication was issued on November 28, 2023.  The FDA is requiring applicants of these medicines to add new warnings about drug reaction with eosinophilia and systemic symptoms to the prescribing information and the Medication Guide for patients and caregivers.

 

FDA warns of rare but serious drug reaction to the antiseizure medicines levetiracetam (Keppra, Keppra XR, Elepsia XR, Spritam) and clobazam (Onfi, Sympazan) | FDA

 

Phyrago (dasatinib)

Sprycel (dasatinib)

Chylothorax

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

Example: Phyrago labeling

Sodium-glucose cotransporter-2 (SGLT2) inhibitors

• Brenzavvy (bexagliflozin)
• Farxiga (dapagliflozin)
• Glyxambi (empagliflozin and linagliptin)
• Inpefa (sotagliflozin)
• Invokana (canagliflozin)
• Invokamet (canagliflozin and metformin hydrochloride tablets)
• Invokamet XR (canagliflozin and metformin hydrochloride tablets)
• Jardiance (empagliflozin)
• Qtern (saxagliptin and dapagliflozin)
• Segluromet (ertugliflozin and metformin)
• Steglatro (ertugliflozin)
• Steglujan (ertugliflozin and sitagliptin)
• Synjardy (empagliflozin and metformin)
• Synjardy XR (empagliflozin and metformin)
• Trijardy XR (empagliflozin, linagliptin, and metformin hydrochloride extended-release tablets)
• Xigduo XR (dapagliflozin and metformin hydrochloride extended-release)

 

Diabetic ketoacidosis

The “Warnings and Precautions” section of the SGLT2 inhibitors product labeling was updated in September 2023 to include prolonged diabetic ketoacidosis and glucosuria.

Example:  Farxiga labeling

Stivarga (regorafenib) Thrombotic microangiopathy

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

Syfovre (pegcetacoplan injection) Retinal vasculitis

The “Warnings and Precautions”, “Postmarketing Experience”, and “Patient Counseling Information” sections of the labeling were updated in November 2023 to include retinal vasculitis and/or retinal vascular occlusion.

Syfovre labeling

 

Topical corticosteroids

 

Skin reaction FDA is evaluating the need for regulatory action.

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