Early Communication From FDA Regarding Potential Singulair Reactions
The U.S. Food and Drug Administration (FDA) has announced that it is working with Merck, Inc., the pharmaceutical company, to explore a possible link between the popular asthma and allergy drug Singulair (known generically as montelukast) and behavioral changes, mood changes, and increased rates of suicide among users. The investigation could take nine months, and although the agency is not yet recommending that anyone stop taking the drug, it is asking health care professionals to monitor Singulair patients for changes in condition that may indicate a suicide risk.
Singulair is used to treat asthma as well as sneezing, stuffy nose, runny nose, and also to prevent exercise-induced asthma. The drug is in a class of drugs known to scientists as leukotriene receptor antagonists. Leukotriene-modifying medications also include the asthma drugs Accolate, Zyflo, and Zyflo CR. The FDA is also reviewing postmarketing reports it has received of behavior and mood changes, suicidality, and suicide in patients who have taken Accolate, Zyflo, and Zyflo CR.
In 40 clinical studies of some 11,000 patients who took Singulair as part of a placebo-controlled trial, there were no reports of suicide, according to Merck spokespeople. Still, the FDA urges caution, and requests that both healthcare professionals and patients report suscpicious side effects related to Singulair, Accolate, Zyflo, and Zyflo CR to the FDA's MedWatch Adverse Event Reporting program:
- on-line at [www.fda.gov/medwatch/report.htm];
- by returning the postage-paid FDA form 3500 [available in PDF format at [www.fda.gov/medwatch/getforms.htm] to 5600 Fishers Lane, Rockville, MD 20852-9787;
- faxing the form to 1-800-FDA-0178; or
- by phone at 1-800-332-1088
Previously on the DC Metro Area Medical Malpractice Law Blog, we have posted articles related to:
- New research indicating that the symptoms of uncontrolled asthma tend to persist after ER visits
- Physician concern over the large numbers of asthmatic children who currently receive no medical care
- How antibiotic use among infants increases their risk of developing asthma
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