25 Drugs, Drug Classes Added to FDA's Safety Signal List

Marcia Frellick

October 21, 2020

The US Food and Drug Administration (FDA) has added 25 drugs or drug classes to its quarterly list of agents in which it has found a potential sign of serious risk or new safety information.

The new list, created from the FDA Adverse Event Reporting System (FAERS), covers April through June, and is current as of October 5.

One large category in this update was the glucagon-like peptide 1 (GLP-1) receptor agonists for type 2 diabetes. The 12 drugs listed in the category had a potential safety signal for hypoglycemia. The FDA is evaluating whether it needs to take regulatory action.

Again this quarter, proton pump inhibitors (PPIs) were prominent on the list. This time the safety signal was hypocalcemia and parathyroid hormone disorders for the 11 drugs listed. The FDA is evaluating whether action is needed for this category as well.

Just because a drug appears on the list does not mean the FDA has found that it is associated with the corresponding risk, only that the agency has identified a potential safety problem. If further review shows that it's associated with risk, the FDA can take action — including requiring label changes, restricting the drug's use, or, in rare cases, removing it from the market.

Here is the updated list:

 

Product Name: Trade (Active Ingredient) or Product Class Potential Signal of a Serious Risk / New Safety Information Additional Information (as of October 5, 2020)
Erenumab-aooe (Aimovig) Wrong strength FDA decided that no action is necessary at this time, based on available information.
Erenumab-aooe (Aimovig) Product preparation error FDA is evaluating the need for regulatory action.
Fremanezumab (Ajovy)
Erenumab-aooe  (Aimovig)
Galcanezumab (Emgality)
Eptinezumab (Vyepti)
Stevens-Johnson syndrome (SJS) FDA is evaluating the need for regulatory action.
Teriflunomide (Aubagio)
Generic products containing teriflunomide
Drug reaction with eosinophilia and systemic symptoms FDA is evaluating the need for regulatory action.
Daratumumab (Darzalex)
Daratumumab and hyaluronidase-fihj (Darzalex Faspro)
Listeriosis FDA is evaluating the need for regulatory action.
Apalutamide (Erleada) Toxic epidermal necrolysis FDA is evaluating the need for regulatory action.
Fibric acid derivatives
  • Fenofibrate (Antara)

  • Fenofibrate (Fenoglide)

  • Fenofibric acid (Fibrocor)

  • Fenofibrate (Lipofen)

  • Fenofibrate (Triglide)

  • Fenofibrate (Tricor)

  • Choline fenofibrate (Trilipix)

  • 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
  • Lixisenatide (Adlyxin)

  • Exenatide (Bydureon)

  • Exenatide (Bydureon BCise)

  • Exenatide (Byetta)

  • Semaglutide (Ozempic)

  • Semaglutide (Rybelsus)

  • Liraglutide (Saxenda)

  •  Insulin glargine and lixisenatide (Soliqua)

  • Albiglutide (Tanzeum)

  • Dulaglutide (Trulicity)

  • Liraglutide (Victoza)

  • Insulin degludec/liraglutide (Xultophy)

Hypoglycemia FDA is evaluating the need for regulatory action.
Palbociclib (Ibrance) Stevens-Johnson syndrome FDA is evaluating the need for regulatory action.
Ado-trastuzumab emtansine (Kadcyla) Skin vascular abnormalities (eg, telangiectasia, spider nevus, spider angioma) FDA decided that no action is necessary at this time, based on available information.
Ribociclib (Kisqali)
Ribociclib, letrozole (Kisqali Femara co-pack)
Stevens-Johnson syndrome FDA is evaluating the need for regulatory action.
Atorvastatin (Lipitor) 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
  • Everolimus (Afinitor)

  • Everolimus (Afinitor Disperz)

  • Temsirolimus (Torisel)

  • Associated generic products containing everolimus or temsirolimus

Radiation recall syndrome FDA is evaluating the need for regulatory action.
Omadacycline tosylate (Nuzyra) Wrong dose FDA decided that no action is necessary at this time, based on available information.
Obeticholic acid (Ocaliva)

Liver disorder

FDA is evaluating the need for regulatory action.
Ocrelizumab (Ocrevus) Hepatitis B reactivation FDA is evaluating the need for regulatory action.
Hydroxychloroquine sulfate (Plaquenil)
Chloroquine phosphate
Generic products containing hydroxychloroquine and chloroquine
Cardiotoxicity FDA is evaluating the need for regulatory action.
Proton pump inhibitors
  • Rabeprazole sodium (Aciphex)

  • Dexlansoprazole (Dexilan)

  • Esomeprazone strontium

  • Esomeprazole magnesium (Nexium)

  • lansoprazole (Prevacid)

  • Omeprazole (Prilosec)

  • Pantoprazole sodium (Protonix)

  • Esomeprazole magnesium and naproxen (Vimovo)

  • Aspirin and omeprazole (Yosprala)

  • Omeprazole and sodium bicarbonate (Zegerid)

  • Generic products containing proton pump inhibitors

Hypocalcemia and parathyroid hormone disorders FDA is evaluating the need for regulatory action.
Buprenorphine (Sublocade) Injection site necrosis FDA is evaluating the need for regulatory action.
Natalizumab (Tysabri) 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.
Lifitegrast (Xiidra) Hypersensitivity FDA decided that no action is necessary at this time, based on available information.
Enzalutamide (Xtandi) Severe cutaneous adverse reactions FDA is evaluating the need for regulatory action.
Onasemnogene abeparvovec-xioi (Zolgensma) Thrombotic microangiopathy FDA is evaluating the need for regulatory action.

 

Marcia Frellick is a freelance journalist based in Chicago. She has previously written for the Chicago Tribune, Science News, and Nurse.com, and was an editor at the Chicago Sun-Times, the Cincinnati Enquirer, and the St. Cloud (Minnesota) Times. Follow her on Twitter at @mfrellick.

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