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FDA probes link between suicidal behaviors and allergy drugs 3-27-08
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.