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 event reports that the safety profile of Singulair hasn't changed," said Dr. Scott Korn, vice president for clinical risk management. "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 choice of 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."
Weldon said that he has not seen any increase in psychiatric problems with the drug, but that some patients had complained of nightmares after starting on Singulair.
"The physician really needs to review whether there are symptoms that have developed since patients started taking the medication, if there's an underlying depression that was there before medication started," added Dr. Rauno Joks, chief of the division of allergy and immunology at SUNY (State University of New York) Downstate in New York City. "Also, seasonal allergies in and of themselves can cause fatigue and lethargy, which makes it harder to assess, because those are some of the symptoms you have with depression."
Joks said he had seen headaches develop as a side effect of Singulair, but not psychiatric problems.
The drug, a leukotriene receptor antagonist that targets part of the body's inflammatory process, is prescribed to treat asthma and the symptoms of allergic rhinitis, as well as to prevent exercise-induced asthma.
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SOURCES: Bloomberg News; Associated Press; David Weldon, M.D., assistant professor, internal medicine, Texas A&M Health Science Center College of Medicine and director, Allergy and Pulmonary Lab Services, Scott & White, College Station; Rauno Joks, M.D., associate professor of clinical medicine, and chief, division of allergy and immunology, SUNY (State University of New York) Downstate, New York City
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