October - December 2017 | Potential Signals of Serious Risks/New Safety Information Identified from 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 |
|---|---|---|
| Cardiovascular adverse events | For Asclera and Sotradecol, the “Warnings and Precautions” section of labeling was updated to include the risk of arterial embolism. No regulatory action was warranted for Varithena. |
| Cytotec (misoprostol) tablets | High fevers (greater than 104 degrees Fahrenheit or 40 degrees Celsius) | The “Precautions” section of labeling was updated to include high fevers greater than 104 degrees Fahrenheit or 40 degrees Celsius. |
| Emend (fosaprepitant) for injection | Infusion site reactions |
Updated
The “Highlights”, “Warnings and Precautions”, and “Patient Counseling Information” sections of the Emend labeling were updated in March 2018 to include infusion site reactions. |
| Erythrocin Lactobionate – IV (erythromycin lactobionate) for injection | Drug interaction with HMG-CoA reductase inhibitors (lovastatin and simvastatin) extensively metabolized by CYP3A4 (enzyme) resulting in myopathy and rhabdomyolysis |
Updated
The “Contraindications” section of the Erythrocin labeling was updated in April 2018 to contraindicate concomitant use of lovastatin and simvastatin. |
| Serious skin reactions |
Updated
FDA decided that no action is necessary at this time based on available information. |
| Lamictal (lamotrigine) tablets | Labetalol-lamotrigine name confusion/medication errors associated with serious outcomes | FDA decided that no action is necessary at this time based on available information. |
| Lexiscan (regadenoson) injection | Serious cardiac adverse events following prolonged Lexiscan administration (>10 seconds) |
Updated
The “Dosage and Administration” and “Warnings and Precautions” sections of the Lexiscan labeling were updated in May 2018 to reinforce adherence to the recommended duration of injection. |
Muscle Relaxants
| Serotonin syndrome |
Updated
FDA decided that no action is necessary at this time based on available information. |
| ProvayBlue (methylene blue) injection | Inappropriate dilution of medication |
Updated
The carton and container labels of ProvayBlue were updated in May 2018 to clarify the appropriate solution for dilution. |
| Singulair (montelukast sodium) tablets | Neuropsychiatric adverse reactions |
Updated
The “Boxed Warning”, “Indications and Usage”, “Warnings and Precautions”, “Overdosage”, “Pharmacokinetics”, “Patient Counseling”, and “Medication Guide” sections of the labeling were updated in April 2020 to include information about the risk of neuropsychiatric events. An FDA Drug Safety Communication was issued on March 4, 2020. |
Sodium-Glucose Cotransporter-2 (SGLT-2) Inhibitors
| Fournier’s gangrene |
Updated
The “Warnings and Precautions”, “Adverse Reactions”, “Patient Counseling Information” and “Medication Guide” sections of the SGLT-2 inhibitor product labeling were updated in October 2018 to include necrotizing fasciitis of the perineum (Fournier’s gangrene). Example: Farxiga labeling |
| Viberzi (eluxadoline) tablets | Anaphylaxis and hypersensitivity | The “Warnings and Precautions” and the “Adverse Reactions” sections of labeling were updated to include hypersensitivity. The Medication Guide was updated to include serious allergic reactions. |