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Page: << Prev | 1 | 2 | 3 | Next >> 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.
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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 information on several adverse events including tremor, depression, suicidality (suicidal thinking and behavior) and anxiousness, according to the FDA.
When the review began, experts pointed out that while it was under way, asthma sufferers needed to determine with their doctors whether Singulair is the best treatment for them.
"[Patients need] to define what they're taking it for," said Dr. David Weldon, director of the Allergy and Pulmonary Lab Services at Scott & White in College Station, Texas. "In some instances, patients may be prescribed Singulair by itself for management of their asthma, and the expert panel guidelines recommend inhaled steroids as the drug of choice for management of asthma as the first line. So if they're still having problems with asthma, they should check with their prescribing physician regarding this."
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