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Last Updated: Apr 16, 2008 - 5:52:06 PM |
TRUSDAY March 27, 2008 (Foodconsumer.org) -- The Food and Drug Administration is investigating a possible link between Merck & Co Inc's Singulair asthma drug and suicidal behavior in adults and children, Reuters reported on Thursday.
The agency was cited as saying it is reviewing the issue after it received reports of mood and behavior changes, suicidal thinking and suicide in patients who were on Singulair, which was first approved in the U.S. in 1998 and indicated to treat allergic symptoms in asthma patients and others.
The link has yet to be established and there has been no reporting of the number of reports the FDA has received, according to Reuters. Merck also declined to say how many reports had been submitted.
The drug maker noted the behavioral risk on Singulair's drug label, but the government now asked the company to assess its data to update the information.
Early Merck stated data on more than 11,000 patients participating in 40 clinical trials did not show signs of suicide or suicidal thoughts or behavior.
The FDA review would take months to complete, according to Reuters. The agency did not give any precaution advice at this time regarding use of Singulair.
Reuters said the FDA is also reviewing reports of behavioral changes in patients using other allergy drugs including AstraZeneca Plc's Accolate and Critical Therapeutics Inc's Zyflo.
The three allergy drugs are known to work on leukotrienes, which are triggered by allergic reactions and lead to inflammation, congestion and other symptoms.
In 2007, Singulair had $4.3 billion in worldwide sales and 3.4 billion in US sales compared to $57.4 million sales in the US for Accolate and about $10 million sales for Zyflo and Zyflo CR, Reuters reported.
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