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  5. FDA's Adverse Event Reporting System (FAERS)
  6. October - December 2019 | Potential Signals of Serious Risks/New Safety Information Identified by the FDA Adverse Event Reporting System (FAERS)
  1. 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 August 5, 2024)

Aimovig (erenumab-aooe)

Hypertension

Updated

The “Warnings and Precautions”, “Adverse Reactions”, and “Patient Counseling Information” sections of the labeling were updated in April 2020 to include risk of hypertension or worsening of pre-existing hypertension.

Aimovig labeling

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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

Updated

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

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

Updated

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

Impavido (miltefosine)

Eye disorders

Updated

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

Myxredlin (insulin human in 0.9% sodium chloride)

Medication error: labeling confusion

Updated

The carton labeling and container label for Myxredlin were updated in June 2020 to increase the prominence of the established name.

Ocrevus (ocrelizumab)

Serious herpes viral infection

Updated

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and the Medication Guide sections of the labeling were updated in May 2020 to include serious herpes infections.

Ocrevus labeling

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)

Updated

The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information”, and the Medication Guide sections of the labeling for prescription proton pump inhibitors were updated in March 2022 to include severe cutaneous adverse reactions.

Example: AcipHex labeling

The "Allergy alert" section of the Drug Facts Label for nonprescription proton pump inhibitors was updated between June 2022 and November 2022 to include severe skin reactions.

Example: Prilosec OTC labeling

The FDA withdrew approval for AcipHex Sprinkle in the Federal Register effective December 1, 2021.

Withdrawal of Approval for AcipHex Sprinkle

Rilutek (riluzole)
Tiglutik (riluzole)

Pancreatitis

Updated

The “Adverse Reactions” section of the labeling was updated in May 2020 to include pancreatitis.

Rilutek labeling

Tiglutik labeling

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
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