Drugs
Potential Signals of Serious Risks/New Safety Information Identified from the Adverse Event Reporting System (AERS) between April - June 2008
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 April - June 2008 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 from the Adverse Event Reporting System (AERS) between April - June 2008
| Product Name: Active Ingredient (Trade) or Product Class |
Potential Signal of Serious Risk/New Safety Information |
Additional Information (as of September 24, 2009) |
|---|---|---|
| Temsirolimus (Torisel) | Labeling confusion resulting in incorrect dose | The FDA/CDER medication error division works closely with the Institute for Safe Medication Practices (ISMP) on some issues. Both FDA and ISMP have been evaluating this issue. The ISMP discussion of the issue is available on the Facts & Comparisons Web site (external link). |
| Levonorgestrel (Plan B) | Syncope and loss of consciousness | FDA decided that no action is necessary at this time based on limited available information. FDA is continuing to monitor the issue. |
| Simvastatin (Zocor) and Amiodarone (Cordarone) | Interaction resulting in rhabdomyolysis |
An FDA Alert on Simvastatin/Amiodarone was issued in August 2008 describing an increased risk of rhabdomyolysis especially with higher doses of simvastatin.
The FDA Drug Safety Newsletter described this issue in Summer 2008.
FDA Patient Safety News featured this story in November 2008.
This drug interaction is included in the labeling. |
| Aripiprazole (Abilify) | Torsades de pointes, hepatotoxicity, and blood dyscrasias |
These issues were identified during a review of aripiprazole adverse events as part of the Post-Marketing Safety Evaluation of New Molecular Entities (NMEs) pilot program. FDA has evaluated these issues and decided that no action is needed at this time. |
| Fluoroquinolone antibiotics | Central nervous system events | FDA added a boxed warning to fluoroquinolone labeling in July 2008 to address another risk, tendonitis and tendon rupture. FDA had considered including central nervous system events such as seizures to the boxed warning. However, FDA decided that these events were already adequately addressed in the Warnings section of labeling. |
| Trazodone | Prolongation of the electrocardiogram QT interval | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Etravirine (Intelence) | Neuropsychiatric events | FDA decided that no action is necessary at this time based on limited available information. FDA is continuing to monitor the issue. |
| Valsartan (Diovan) | Hemolytic anemia | FDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue. |
| Furosemide (Lasix), Torsemide (Demadex), Spironolactone (Aldactone) | Serious skin reactions | FDA is evaluating this issue to determine if labeling is adequate for these three diuretic products. |
| Orlistat (Xenical) | Rectal bleeding | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Leukotriene receptor antagonists | Suicidal behavior and suicide |
FDA issued an Early Communication on this topic in March 2008 and an update in January 2009. In August 2009 the Early Communication was again updated to announce the addition of neuropsychiatric events to the Precautions section of labeling for these products. |
| Phenylephrine HCl Injection | Labeling confusion resulting in incorrect dose and overdose | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Propafenone (Rythmol) | Hepatotoxicity | FDA is continuing to evaluate this issue to determine the need for any regulatory action. |
| Sulfonylurea antidiabetic drugs | Hemolytic anemia in patients with and without G6PD deficiency |
FDA has requested class labeling to add this information to the Precautions section of the labeling for all sulfonylurea products. Refer to the August 2009 Drug Safety Labeling Changes summary page, listing products with "sulfonylurea agent change," on the MedWatch Web site. |
