March 21, 2010

Popular allergy, asthma medication under investigation

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By Jennifer Brice

Story Published: Mar 28, 2008 at 12:53 AM EDT

Story Updated: Mar 28, 2008 at 1:49 PM EDT

With allergy season upon us, many people are reaching into the medicine cabinet to find relief. This as a warning comes about the popular allergy and asthma medication called Singulair. It's taken by millions of Americans, many of them children.

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Today the Food and Drug Administration announced it "is investigating a possible association between the use of Singulair and behavior/mood changes, suicidal thinking and behavior, and suicide."

Cody Miller was an active 15 year old with asthma who was prescribed Singulair. His mother says his behavior changed quickly. "Second week he started having some issues with, not sleeping well,” she says. “Then sleeping like long periods of time. And leg aches and just kind of agitated behavior."

Soon afterward he killed himself.

The FDA says it has received 3 or 4 such reports of suicides after people started taking the drug but it has not established cause and effect. They are now investigating a possible association between the use of Singulair and behavior/mood changes, suicidal thinking and behavior, and suicide.

In a statement today Merck, the company that makes the drug, said it was cooperating with the FDA. It emphasized that "the fact that an adverse event has been reported to Merck and to regulatory agencies does not mean the event is caused by Singulair."

The FDA says the investigations could take as long as nine months.

In response to complaints it has heard, Merck has updated the label four times in the past year to include warnings about "tremor", "depression", "suicidal" and "anxiousness."

Sales of the drug exceed $4-billion a year.

Jennifer Brice reports.

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