FDA Probing Possible Link Between Asthma Drug and Suicide Risk

Singulair, top-selling drug for teens, under review by U.S. agency and manufacturer Merck

By Amanda Gardner
HealthDay Reporter

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THURSDAY, March 27 (HealthDay News) -- The U.S. Food and Drug Administration said Thursday it was investigating the possibility of an increased risk of mood changes and suicidal behavior among those who take the highly popular asthma drug Singulair.

Singulair is the number one-selling drug among people aged 17 and younger. Last year, it posted sales of $4.3 billion, making it Merck & Co.'s top-selling product, according to the Associated Press.

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In issuing its statement, the FDA stressed that asthma patients should not stop taking Singulair without talking to their doctor first.

Both Merck and the FDA noted that the two have been working together over the past year to determine the scope of the problem and to make appropriate labeling changes to reflect the potential risk of mood changes and suicidal behavior among Singulair users.

"Suicide has been reported to us only in post-marketing experience in anecdotal reports that come to the company," George Philip, head of Merck's Singulair development program, told Bloomberg News. The company declined to say how many suicides have been reported, saying only that it is a "very small number" relative to the amount of people taking the drug.

The company also released a statement Thursday that detailed the ongoing review.

"Merck voluntarily updated the worldwide product label for Singulair in October 2007 to include 'suicidal thinking and behavior' and included similar changes to the patient product information," the company said in its statement. "These actions were based on a very limited number of post-marketing adverse event reports that Merck has received. Since that time, Merck has worked with the U.S. Food and Drug Administration to provide further clarity in the product label as well as to further communicate this information to physicians."

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