FDA Probes Allergy Drug's Suicide Link

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FDA probes allergy drug's suicide link The government is investigating Merck's

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The FDA is investigating a possible link between Merck's

allergy drug Singulair and suicide.

 

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WASHINGTON (AP) -- 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 (MRK, Fortune 500) 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.

 

The agency recently began notifying the public earlier about possible safety

issues. The policy change came after the FDA was criticized for acting too

slowly on information about the risks of Merck's painkiller Vioxx and,

GlaxoSmithKline (GSK) plc's diabetes pill Avandia.

Merck officials stressed that the FDA's inquiry is based on reports, not

clinical studies -- which are the standard tool for evaluating drug safety. The

company said none of the 11,000 patients enrolled in 40 Singulair trials has

committed suicide.

 

" We have no indication that anything about the mechanism of Singulair is

consistent with these events, " said George Philip, director of research and

product development. " But because suicide is a life-threatening event we thought

it was important to provide this information in the product label. "

 

Merck said it recently added reports of suicide to Singulair's label, which

already listed suicidal thinking and behavior as reported side effects.

In clinical trials of asthma patients, the most common side effects were

headache, flu, abdominal pain and cough.

 

With sales of $4.3 billion last year, Singulair is used by millions of

patients in the United States, according to Merck. First approved in 1998, it's

part of a class of asthma and allergy drugs that includes AstraZeneca's Accolate

and Critical Therapeutics's Zyflo.

FDA said it is also reviewing reports of side effects with those drugs. Their

labeling does not contain language about suicide.

 

" Patients should not stop taking Singulair before talking to their doctor, "

FDA said in its statement, adding that doctors should monitor patients for

suicidal behavior and mood changes.

 

 

 

 

 

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