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U.S. Department of Health and Human Services

Drugs

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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 August 1, 2013)

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.

Etravirine (Intelence)Neuropsychiatric eventsFDA decided that no action is necessary at this time based on limited available information. FDA is continuing to monitor the issue.
Fluoroquinolone antibioticsCentral nervous system eventsFDA added a boxed warning to fluoroquinolone labeling in July 2008 to address another risk, tendinitis 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.
Furosemide (Lasix), Torsemide (Demadex), Spironolactone (Aldactone)Serious skin reactions

No further regulatory action is planned at this time.

The Adverse Reactions section of the labeling for Lasix (furosemide) was updated October 2010, to reflect this issue.

Furosemide (Lasix) Labeling approved October 18, 2010 (PDF - 138KB)

The Adverse Reactions section of the labeling for Demadex (torsemide) was updated January 2010 to reflect this issue.

 

Torsemide (Demadex) Labeling approved January 27, 2010 (PDF - 93KB)

Leukotriene receptor antagonistsSuicidal 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. FDA approved the new labeling for these products on August 19, 2009.

Updated Information on Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)

Levonorgestrel (Plan B)Syncope and loss of consciousnessFDA decided that no action is necessary at this time based on limited available information. FDA is continuing to monitor the issue.
Orlistat (Xenical, Alli)Rectal bleeding

The Adverse Events section of the labeling for Xenical was updated January 2012 to include lower gastrointestinal bleeding.

Orlistat (Xenical) Labeling approved January 20, 2012 (PDF - 408KB)

FDA decided that the current labeling for Alli is adequate and that no further action is necessary at this time based on available information.

Phenylephrine HCl InjectionLabeling 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 decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.

Simvastatin (Zocor) and Amiodarone (Cordarone)Interaction resulting in rhabdomyolysis

No further regulatory action is planned at this time.

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.

The Dosage and Administration section of the labeling for Simvastatin was updated June 2011, and revised October 2011, to restrict use of the 80 mg dose.

Zocor (Simvastatin) Labeling approved October 6, 2011 (PDF - 222KB)

Amiodarone (Cordarone) Labeling approved November 19, 2009 (PDF - 988KB)

Sulfonylurea antidiabetic drugsHemolytic anemia in patients with and without G6PD deficiency

No further regulatory action is planned at this time.

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.

The Precautions sections of the Avandaryl (rosiglitazone maleate and glimepiride) and Glucovance (glyburide and metformin HCl) labeling was updated November 2009 to reflect this issue.

November 2009 Drug Safety Labeling Changes summary page

Drug labeling for specific products is available from DailyMed or Drugs@FDA.

Temsirolimus (Torisel)Labeling confusion resulting in incorrect dose

The Dosage and Administration section of the labeling for Torisel was updated June 2011, to address this issue.

Temsirolimus (Torisel) Labeling approved June 16, 2011 (PDF - 220KB)

The ISMP discussion of the issue Exit Disclaimer is available on the Facts & Comparisons Web site.

TrazodoneProlongation of the electrocardiogram QT interval

The Warnings and Precautions section of the labeling for Trazodone hydrochloride extended release (Oleptro) was updated to reflect this issue.

Trazodone hydrochloride extended release (Oleptro) Labeling approved February 2, 2010 (PDF – 238KB)

FDA decided that no further action is necessary at this time based on available information. FDA is continuing to monitor the issue.

Valsartan (Diovan)Hemolytic anemiaFDA decided that no action is necessary at this time based on available information. FDA is continuing to monitor the issue.