FDA: Asthma Drugs Pose No Suicide Risk
Posted on: Wednesday, 14 January 2009, 14:42 CST
Following an investigation, federal health officials claim to have found no link between asthma drugs, such as Merck and Co. Inc.’s Singulair and an increased risk of suicide.
The FDA announced on Tuesday that investigations are ongoing, but officials have discovered no link between the drugs and behavioral problems.
"We have finished our analyses of all the data the companies submitted," said FDA spokeswoman Karen Riley. "But that doesn't mean we have closed the book on suicidality."
In late March 2008 the FDA released an early communication about the ongoing investigation between the use of Singulair and “behavior/mood changes, suicidality (suicidal thinking and behavior) and suicide.”
In March, the FDA estimated that it could take up to 9 months to complete the ongoing evaluations, “due to the complexity of the analyses.” At the time, the agency recommended that healthcare professionals and caregivers should monitor patients taking Singulair for suicidality.
Singulair is used for the treatment of asthma and symptoms of allergic rhinitis.
After reviewing dozens of company studies, the FDA said the drugs do not appear to be associated with increased risk of suicide.
"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."
Regulators said that only one in nearly 10,000 patients taking Singulair in clinical trials reported suicidal tendencies. No patients committed suicide.
AstraZeneca submitted results from 45 placebo-controlled trials in which 7,540 patients were treated with Accolate, according to the Washington Post. Only one patient in the placebo group attempted suicide, and another considered it.
"We will communicate our conclusions and any resulting recommendations to the public at the conclusion of the review," said the agency.
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Source: redOrbit Staff & Wire Reports
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