Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) between January – March 2010
The table below lists the names of products and potential signals of serious risks/new safety information that were identified for these products during the period January – March 2010 in the AERS database. The appearance of a drug on this list does not mean that FDA has concluded that the drug has the listed risk. It means that FDA has identified a potential safety issue, but does not mean that FDA has identified a causal relationship between the drug and the listed risk. If after further evaluation the FDA determines that the drug is associated with the risk, it may take a variety of actions including requiring changes to the labeling of the drug, requiring development of a Risk Evaluation and Mitigation Strategy (REMS), or gathering additional data to better characterize the risk.
FDA wants to emphasize that the listing of a drug and a potential safety issue on this Web site does not mean that FDA is suggesting prescribers should not prescribe the drug or that patients taking the drug should stop taking the medication. Patients who have questions about their use of the identified drug should contact their health care provider. FDA will complete its evaluation of each potential signal/new safety information and issue additional public communications as appropriate.
Potential Signals of Serious Risks/New Safety Information Identified by the Adverse Event Reporting System (AERS) January – March 2010
| Product Name: Active Ingredient (Trade) or Product Class |
Potential Signal of a Serious Risk / New Safety Information |
Additional Information
(as of October 31, 2010) |
| Azacitidine (Vidaza) |
Acute febrile neutrophilic dermatosis (Sweet’s syndrome) |
FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Azithromycin (Zithromax) |
Liver failure |
FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Azithromycin extended release 2 g (Zmax) |
Pyloric stenosis |
FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| C1 esterase inhibitors (Cinryze, Berinert) |
Thromboembolic events in patients with certain thrombogenic risk factors |
FDA is evaluating this issue to determine whether current labeling is adequate. |
| Clarithromycin (Biaxin) |
Liver failure |
FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Daptomycin (Cubicin) |
Pulmonary eosinophilia, Eosinophilic pneumonia |
FDA Drug Safety Communication1
The Warnings and Precautions section of the labeling for Cubicin was updated September 2010, to include pulmonary eosinophilia and eosinophilic pneumonia.
Daptomycin (Cubicin) Labeling approved August 13, 2010 (PDF – 236KB)2 |
| Dronedarone hydrochloride (Multaq) |
Congestive heart failure |
FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Estrogens, conjugated (Premarin) |
Angioedema |
FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Modafinil (Provigil) |
Convulsion |
FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Prasugrel hydrochloride (Effient) |
Thrombotic thrombocytopenic purpura |
FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Ranolazine (Ranexa) |
Torsades de Pointes |
FDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue. |
| Sodium oxybate (Xyrem) |
Convulsion |
FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Temsirolimus (Torisel) |
Infusion site extravasation |
FDA is continuing to evaluate this issue to determine the need for any regulatory action. |