Singulair, top-selling drug for teens, plus Accolate and Zyflo show no behavioral changes in trials submitted by manufacturers, agency says; safety review to continue
WEDNESDAY, Jan. 14 (HealthDay News) -- An ongoing U.S. Food and Drug Administration safety review of possible suicidal behavior among those taking asthma drugs has found no evidence of a link so far, agency officials said Tuesday.
The FDA, which began the review in March 2008, said clinical trial data submitted by the manufacturers of Singulair, Accolate and Zyflo suggest the products are not associated with an increased risk of mood changes or suicidal behavior.
But, the agency also noted that the trials were not designed to examine such behavior, and that the safety review will continue, probably for several more months.
"We have finished our analyses of all the data the companies submitted," FDA spokeswoman Karen Riley told the Associated Press. "But that doesn't mean we have closed the book on suicidality."
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.
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 Tuesday that the company has turned over extensive records to the FDA.
"We still believe, after a thorough review of our clinical trial data and post-marketing
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