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Asthma Drugs Get 'Precaution' Labeling for Possible Psychiatric Side Effects
Date:6/12/2009

d cases of neuropsychiatric events," according to the agency statement. "Some reports included clinical details consistent with a drug-induced effect. In the clinical trial data submitted by manufacturers, neuropsychiatric events were not commonly observed. However, the available data were limited because the trials were not designed to look for neuropsychiatric events. Sleep disorders [primarily insomnia] were reported more frequently with all three products compared to placebo."

According to Bloomberg News, Merck & Co submitted results from 41 placebo-controlled trials involving 9,929 patients treated with Singulair, which is the top-selling drug for people under 17 years old. One adult patient treated with Singulair had suicidal thoughts, and there were no suicides, according to the FDA report.

A spokeswoman for Merck told the AP Friday that the precaution is already included in Singulair's labeling; it will simply be moved from a section on side effects to a higher section on "precautions."

AstraZeneca submitted results from 45 placebo-controlled trials in which 7,540 patients were treated with Accolate. The FDA said one patient in an accompanying placebo group attempted suicide, and another thought about it. No Accolate patients reported any suicidal behavior. The FDA also said Cornerstone submitted information showing no suicidal behavior among Zyflo users.

A Merck executive told the AP in January that the company had turned over extensive records to the FDA.

"We still believe, after a thorough review of our clinical trial data and postmarketing event reports that the safety profile of Singulair hasn't changed," Dr. Scott Korn, vice president for clinical risk management, said at the time. "We look forward to discussions with the FDA after they've completed their work."

Before last year's review began, Merck had updated prescribing information for Singulair to include infor
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