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. |
|
Epclusa (sofosbuvir and velpatasvir) |
Interaction with bariatric surgery: treatment failure |
FDA is evaluating the need for regulatory action. |
|
Glucagon-like peptide-1 (GLP-1) receptor agonists (RAs)
|
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
|
Acute generalized exanthematous pustulosis (AGEP) |
FDA is evaluating the need for regulatory action. |
|
Rilutek (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 |