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FDA Probing Possible Link Between Asthma Drug and Suicide Risk
Date:3/27/2008

the U.S. Food and Drug Administration to provide further clarity in the product label as well as to further communicate this information to physicians."

Over the past year, Merck has updated prescribing information for the drug to include information on several adverse events including tremor, depression, suicidality (suicidal thinking and behavior) and anxiousness, according to the FDA. And Merck plans to convey recent labeling changes in face-to-face meetings with prescribers and also in patient leaflets.

The FDA has asked Merck to look at Singulair study data for more information about suicidality and suicide. The agency itself is reviewing post-marketing reports of adverse events.

In its statement, Merck detailed the nature of those adverse events. "In a cumulative analysis recently provided to the FDA of Merck's randomized, double-blind, placebo-controlled clinical trials, which included over 11,000 adults and children in over 40 studies who were treated with Singulair, there were no reports of suicidal thoughts or actions and no completed suicides in the patients who received Singulair," the statement read. "Additionally, in a cumulative analysis recently provided to the FDA of Merck's randomized, double-blind, clinical trials that compared Singulair with other active agents to treat asthma [which included over 3,900 adults and children who were treated with Singulair and over 3,400 who were treated with other asthma therapies], there was one patient who attempted suicide who received Singulair, and there were three patients who attempted suicide who received other asthma therapies [including inhaled corticosteroids and long-acting beta-agonists]."

The FDA noted it was also looking into whether other related drugs, such as Accolate, Zyflo and Zyflo CR need to be investigated as well.

"Due to the complexity of the analyses," the FDA said, it anticipates that it may take up to nine months to complete the ongo
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