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  6. April - June 2020 | 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)

April - June 2020 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)

 

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information
(as of September 28, 2020)

Aimovig (erenumab-aooe)

Wrong strength

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

Aimovig (erenumab-aooe)

Product preparation error

FDA is evaluating the need for regulatory action.

Ajovy (fremanezumab)
Aimovig (erenumab-aooe)
Emgality (galcanezumab)
Vyepti (eptinezumab)

Stevens-Johnson syndrome (SJS)

FDA is evaluating the need for regulatory action.

Aubagio (teriflunomide)
Generic products containing teriflunomide

Drug reaction with eosinophilia and systemic symptoms

FDA is evaluating the need for regulatory action.

Darzalex (daratumumab)
Darzalex Faspro (daratumumab and hyaluronidase-fihj)

Listeriosis

FDA is evaluating the need for regulatory action.

 Erleada (apalutamide)

Toxic epidermal necrolysis

FDA is evaluating the need for regulatory action.

Fibric acid derivatives

  • Antara (fenofibrate)
  • Fenoglide (fenofibrate)
  • Fibrocor (fenofibric acid)
  • Lipofen (fenofibrate)
  • Triglide (fenofibrate)
  • Tricor (fenofibrate)
  • Trilipix (choline fenofibrate)
  • Generic products containing fibric acid derivatives

Drug-induced liver injury

FDA is evaluating the need for regulatory action.

Glucagon-like peptide 1 (GLP-1) Receptor Agonists

  • Adlyxin (lixisenatide)
  • Bydureon (exenatide)
  • Bydureon BCise (exenatide)
  • Byetta (exenatide)
  • Ozempic (semaglutide)
  • Rybelsus (semaglutide)
  • Saxenda (liraglutide)
  • Soliqua (insulin glargine and lixisenatide)
  • Tanzeum (albiglutide)
  • Trulicity (dulaglutide)
  • Victoza (liraglutide)
  • Xultophy (insulin degludec/liraglutide)

Hypoglycaemia

FDA is evaluating the need for regulatory action.

Ibrance (palbociclib)

Stevens-Johnson syndrome

FDA is evaluating the need for regulatory action.

Kadcyla (ado-trastuzumab emtansine)

Skin vascular abnormalities (e.g., telangiectasia, spider nevus, spider angioma)

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

Kisqali (ribociclib)
Kisqali Femara co-pack (ribociclib, letrozole)

Stevens-Johnson syndrome

FDA is evaluating the need for regulatory action.

Lipitor (atorvastatin)

Drug interaction between atorvastatin and hepatitis C virus (HCV) NS5A/NS5B inhibitors

FDA is evaluating the need for regulatory action.

Mammalian target of rapamycin (mTOR) inhibitors

  • Afinitor (everolimus)
  • Afinitor Disperz (everolimus)
  • Torisel (temsirolimus)
  • Associated generic products containing everolimus or temsirolimus

Radiation recall syndrome

FDA is evaluating the need for regulatory action.

Nuzyra (omadacycline tosylate)

Wrong dose

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

Ocaliva (obeticholic acid)

Liver disorder

FDA is evaluating the need for regulatory action.

Ocrevus (ocrelizumab)

Hepatitis B reactivation

FDA is evaluating the need for regulatory action.

Plaquenil (hydroxychloroquine sulfate)
Chloroquine phosphate
Generic products containing hydroxychloroquine and chloroquine

Cardiotoxicity

FDA is evaluating the need for regulatory action.

Proton Pump Inhibitors

  • Aciphex (rabeprazole sodium)
  • Dexilan (dexlansoprazole)
  • Esomeprazone strontium
  • Nexium (esomeprazole magnesium)
  • Prevacid (lansoprazole)
  • Prilosec (omeprazole)
  • Protonix (pantoprazole sodium)
  • Vimovo (esomeprazole magnesium and naproxen)
  • Yosprala (aspirin and omeprazole)
  • Zegerid (omeprazole and sodium bicarbonate)
  • Generic products containing proton pump inhibitors

Hypocalcemia and parathyroid hormone disorders

FDA is evaluating the need for regulatory action.

Sublocade (buprenorphine)

Injection site necrosis

FDA is evaluating the need for regulatory action.

Tysabri (natalizumab)

Neonatal thrombocytopenia

FDA is evaluating the need for regulatory action.

Vinca alkaloids

  • Vincristine sulfate
  • Vinblastine sulfate
  • Vinorelbine tartrate

Incorrect route of product administration

FDA is evaluating the need for regulatory action.

Xiidra (lifitegrast)

Hypersensitivity

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

Xtandi (enzalutamide)

Severe cutaneous adverse reactions

FDA is evaluating the need for regulatory action.

Zolgensma
(onasemnogene abeparvovec-xioi)

Thrombotic microangiopathy

FDA is evaluating the need for regulatory action.

 

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