FDA: Singular, Zyflo Asthma Drug Safety Review Continues
January 13 2009 - 3:34PM
Dow Jones News
The U.S. Food and Drug Administration said Tuesday it's
continuing a safety review of Singulair and similar asthma
medications to see if they are linked to mood and behavior changes
including suicide.
The agency said the safety review, first announced last March,
"may take months to complete."
The FDA previously said it was looking at post-marketing reports
involving Merck & Co.'s (MRK) Singulair and asked the company
to submit additional information. The agency also asked the
manufacturers of drugs that work in a similar manner to Singulair
to submit information. Accolate is made by AstraZeneca PLC (AZN)
and Zyflo is made by Cornerstone Therapeutics Inc. (CRTX).
The agency said Merck submitted results from 41
placebo-controlled clinical trials in which 9,929 patients were
treated with Singulair and 7,780 were treated with a placebo. One
adult patient out of 9,929 patients treated with Singulair had
suicidal thoughts and there were no completed suicides.
The FDA said AstraZeneca submitted results from 45
placebo-controlled clinical trials in which 7,540 patients were
treated with Accolate and 4,659 were treated with a placebo. The
agency said one patient in the placebo group attempted suicide and
another thought about suicide. No patients on Accolate reported any
suicidal behavior. The FDA said information submitted by
Cornerstone showed no suicidal behavior in either the Zyflo groups
or placebo groups.
The FDA said although it appears the data submitted by the
companies would suggest the products aren't associated with suicide
or suicidal behavior, it noted that the trials weren't designed to
look at such behavior.
The agency said it was continuing to review clinical trial data
to assess other neuropsychiatric events such as mood and behavioral
adverse events related to the drug.
-By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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