UPDATE: Singular, Zyflo Asthma Drug Safety Review Continues
14 January 2009 - 9:33AM
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.
Last March the FDA began a safety review of Singulair, made by
Merck & Co. (MRK) to see if the drug was linked to behavior
changes, suicidal thinking and suicide, and asked Merck and
manufacturers of drugs of similar drugs - Accolate by AstraZeneca
PLC (AZN) and Zyflo, by Cornerstone Therapeutics Inc. (CRTX) - to
submit additional information. However, Tuesday the agency said
that a safety review of the class of medications is ongoing and
"may take months to complete."
Singulair, first approved in the U.S. in 1998 is Merck's
top-selling product and had $4.3 billion in sales in 2007 and is
the dominant drug in its class. The product is approved for use in
children and adults ages 12 months and older as an asthma and
allergy treatment.
The FDA 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.
In a statement, Merck said it "agreed" with the FDA's statement
that the clinical data suggested Singulair wasn't associated with
suicide or suicidal behavior. Singulair's label already discusses
post-marketing reports of reports of suicidal thinking and other
neuropsychiatric events like depression.
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 and has "not yet reached a
definitive conclusion regarding the clinical trial data on mood and
behavioral adverse events associated" with the three drugs.
- By Jennifer Corbett Dooren, Dow Jones Newswires; 202-862-9294;
jennifer.corbett@dowjones.com
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