July - September 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
The drug product(s) included in any of the potential signals of serious risks/new safety information listed below may also include the generic version of the drug product(s), if there are generic versions approved for use by the FDA at the time of this publication.
Product Name: Trade (Active Ingredient) or Product Class | Potential Signal of a Serious Risk / New Safety Information | Additional Information (as of December 12, 2023) |
---|---|---|
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. |
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) |
Enterocolitis |
FDA is evaluating the need for regulatory action. |
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
|
Haemophagocytic lymphohistiocytosis |
FDA is evaluating the need for regulatory action. |
BCMA- or CD19-directed genetically modified autologous T-cell immunotherapies
|
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 is evaluating the need for regulatory action. |
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.
|
Gemcitabine Infugem (gemcitabine in sodium chloride injection) |
Drug reaction with eosinophilia and systemic symptoms |
FDA is evaluating the need for regulatory action. |
Gilenya (fingolimod) Mayzent (siponimod) Ponvory (ponesimod) Tascenso ODT (fingolimod) Zeposia (ozanimod)
|
Progressive multifocal leukoencephalopathy |
FDA is evaluating the need for regulatory action. |
Glucagon-like peptide-1 (GLP-1) receptor agonists
|
Alopecia |
FDA is evaluating the need for regulatory action. |
Glucagon-like peptide-1 (GLP-1) receptor agonists
|
Aspiration |
FDA is evaluating the need for regulatory action. |
Glucagon-like peptide-1 (GLP-1) receptor agonists
|
Suicidal ideation |
FDA is evaluating the need for regulatory action. |
Kyprolis (carfilzomib) Ninlaro (ixazomib) |
Anaphylactic reaction |
FDA is evaluating the need for regulatory action. |
Lupkynis (voclosporin)
|
Nausea and vomiting symptoms |
FDA is evaluating the need for regulatory action. |
Ocrevus (ocrelizumab) |
Drug-induced liver injury |
FDA is evaluating the need for regulatory action. |
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.
|
Phyrago (dasatinib) Sprycel (dasatinib) |
Chylothorax | FDA is evaluating the need for regulatory action. |
Sodium-glucose cotransporter-2 (SGLT2) inhibitors
|
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 is evaluating the need for regulatory action. |
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.
|
Topical corticosteroids
|
Skin reaction |
FDA is evaluating the need for regulatory action. |