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  6. October - December 2019 | 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)

October - December 2019 | 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 March 19, 2020)

Aimovig (erenumab-aooe)

Hypertension

FDA is evaluating the need for regulatory action.

Belsomra (suvorexant)

Fall, serious injuries

The "Warnings and Precautions," "Adverse Reactions," "Use in Specific Populations," and "Patient Counseling Information" sections of the labeling were updated January 2020, to include falls.
Belsomra label

Epclusa (sofosbuvir and velpatasvir)
Harvoni (ledipasvir and sofosbuvir)
Vosevi (sofosbuvir, velpatasvir, and voxilaprevir)

Interaction with bariatric surgery: treatment failure

FDA is evaluating the need for regulatory action.

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

  • Adlyxin (lixisenatide)
  • Byetta (exenatide)
  • Bydureon (exenatide)
  • Bydureon BCISE (exenatide)
  • Ozempic (semaglutide)
  • Rybelsus (semaglutide)
  • Saxenda (liraglutide)
  • Soliqua (insulin glargine and lixisenatide)
  • Tanzeum (albiglutide)
  • Trulicity (dulaglutide)
  • Victoza (liraglutide)
  • Xultophy 100/3.6 (insulin degludec and liraglutide)

Diabetic ketoacidosis

FDA is evaluating the need for regulatory action.

Impavido (miltefosine)

Eye disorders

FDA is evaluating the need for regulatory action.

Myxredlin (insulin human in 0.9% sodium chloride)

Medication error: labeling confusion

FDA is evaluating the need for regulatory action.

Ocrevus (ocrelizumab)

Serious herpes viral infection

FDA is evaluating the need for regulatory action.

Proton pump inhibitors

  • AcipHex (rabeprazole sodium)
  • AcipHex Sprinkle (rabeprazole sodium)
  • Dexilant (dexlansoprazole)
  • Nexium (esomeprazole magnesium)
  • Nexium IV (esomeprazole sodium)
  • Nexium 24 HR (esomeprazole magnesium)
  • Prevacid (lansoprazole)
  • Prevacid 24HR (lansoprazole)
  • Prevacid SoluTab (lansoprazole)
  • Prilosec (omeprazole)
  • Prilosec OTC (omeprazole magnesium)
  • Protonix (pantoprazole sodium)
  • Protonix IV (pantoprazole sodium)
  • Vimovo (esomeprazole magnesium and naproxen)
  • Yosprala (aspirin and omeprazole)
  • Zegerid (omeprazole and sodium bicarbonate)
  • Zegerid OTC (omeprazole and sodium bicarbonate)
  • Generic products containing proton pump inhibitors

Acute generalized exanthematous pustulosis (AGEP)

FDA is evaluating the need for regulatory action.

Rilutek (riluzole)
Tiglutik (riluzole)

Pancreatitis

FDA is evaluating the need for regulatory action.

Vasostrict (vasopressin)

Diabetes insipidus

The “Warnings and Precautions” and “Adverse Reactions” sections of the labeling were updated to include the risk of diabetes insipidus.

Vasostrict labeling