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  6. July - September 2023 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. Questions and Answers on FDA's Adverse Event Reporting System (FAERS)

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.

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)

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

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

Post-treatment T-cell malignancy

FDA is evaluating the need for regulatory action.

FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies

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.

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

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

  • 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

FDA is evaluating the need for regulatory action.

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

FDA is evaluating the need for regulatory action.

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

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.

 

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 FDA is evaluating the need for regulatory action.

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 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.

Syfovre labeling

 

Topical corticosteroids

 

Skin reaction

FDA is evaluating the need for regulatory action.

 
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