Author: turtoniturtoni Date: Mar 27, 2008 20:56
John??
"NEW YORK -- The Food and Drug Administration said Thursday it is
investigating a possible link between Merck's best-selling Singulair
and suicide.
FDA said it is reviewing a handful of reports involving mood changes,
suicidal behavior and suicide in patients who have taken the popular
allergy and asthma drug.
Merck has updated the drug's labeling four times in the past year to
include information on a range of reported side effects: tremors,
anxiousness, depression and suicidal behavior.
FDA said it asked the Whitehouse, N.J.-based company to dig deeper
into its data on Singulair for evidence of possible links to suicide.
The agency said it has not established a "causal relationship" between
Merck's drug and suicidal behavior. An agency spokeswoman said the
review was prompted by three to four suicide reports it received since
last October.
It could take up to nine months before agency scientists can draw any
conclusions, FDA said in a posting to its Web site.
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