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 |
FDA is evaluating the need for regulatory action. |
|
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 |
FDA is evaluating the need for regulatory action. |
|
Serious skin reactions |
FDA is evaluating the need for regulatory action |
|
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) |
FDA is evaluating the need for regulatory action. |
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Muscle Relaxants
|
Serotonin syndrome |
FDA is evaluating the need for regulatory action. |
|
ProvayBlue (methylene blue) injection |
Inappropriate dilution of medication |
FDA is evaluating the need for regulatory action. |
|
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 |
FDA is evaluating the need for regulatory action. |
|
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. |