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March 27, 2008 (Bloomberg) -- Merck & Co.'s Singulair may be linked to suicide as well as changes
in mood and behavior, U.S. regulators said on March 27, 2008 in announcing a review of the company's top-selling
asthma drug.
The Food and Drug Administration is working with Whitehouse Station, New Jersey-based Merck to evaluate
studies and patient reports, the agency said today in a
notice on its Web site. The examination may take as long as nine months, the FDA said. The company declined
to say how many deaths were reported.
The FDA is also reviewing reports of suicide and behavioral changes in people who took AstraZeneca Plc's
Accolate and Critical Therapeutics Inc.'s Zyflo and Zyflo CR, three asthma medicines that are similar to Singulair.
The agency said it will decide after the review if further investigation is warranted.
Drug-induced behavior changes and suicide risk have come under increased scrutiny by regulators, leading to
warnings for a growing list of medications including antidepressants, and treatments for attention deficit
hyperactivity disorder and epilepsy. Last month, the FDA warned that Pfizer Inc.'s anti-smoking drug Chantix may
raise the risk of psychiatric disorders after 39 patients committed suicide while taking the medicine.
If you or a loved one have taken any of these drugs and experienced a death in the family, please
contact our office for a free case evaluation.
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