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. Emend labeling |
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 |
FDA is evaluating the need for regulatory action. |
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. |