FDA Investigates Merck Allergy Drug's Possible Link To Suicide

WASHINGTON — 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.

With sales of $4.3 billion last year, Singulair is used by millions of patients in the U.S, according to Merck. First approved in 1998, it's part of a class of asthma and allergy drugs that includes AstraZeneca PLC's Accolate and Critical Therapeutics Inc.'s Zyflo.

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."

"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.

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 before 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 PLC's diabetes pill Avandia.

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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.

The company 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.

FDA said it is also reviewing reports of side effects with rival drugs, such as Accolate and Zyflo. Their labeling does not contain language about suicide.

Dr. Rauno Joks, an allergy specialist, said Thursday Singulair is generally well tolerated by his patients.

"Some of them have headaches with it but nothing I could imagine developing into depression or suicide," said Joks, head of the allergy division at State University of New York's Downstate Medical Center.

Joks said he will continue prescribing the drug because there are few alternatives for asthma patients beyond inhalable steroids, the standard treatment for the disease.

Shares of Merck & Co. gained 3 cents in after-hours trading Thursday, following an earlier close at $44.78, up 8 cents for the day.

Comments

[jedennis]

I don't know what the FDA will come up with, but from my experience over the past eight years, Singulair is a godsend! Due to severe problems with asthma, allergies and sinus infections which led to lots of sleepless nights I occasionally had suicidal thoughts before Singulair. After being on a few months the relief provided by this medicine has gave me a complete new life. I sincerely hope it isn't taken off the market!

[dax49]

i can just bet that the FDA will clear them. any bets?

[Stretchumall]

This will be the last we hear of this.

[Boboday555]

I wouldn't be at all surprised if the FDA blamed the suicide victims.

[outnow]

But I don't sneeze when I'm dead! Just so long as they make record profits each quarter who in America cares? Sure, if it is you or your child but when its someone else, it's those lawyers!!!!!!!

Money is the false God of America. We have to substitute a higher value than the pursuit of money. If the events of the past twenty years don't convince you, then go back thirty, or forty. Oh, what the hell, go back to when we had slaves and sold tobacco to save the economy of the Jamestown colony after the first settlement died out.

When will we hold the corporate Gods to account for their fraud?

[groovychaos]

i agree with the message of your post - i walk through my days in a sort of duel existence. in one respect, i have to function in this society therefore i "play by the rules" and play the game. on the other hand, i do not care a whit about money and my oh-so-casual approach to money confounds so many of my friends and family members. it is nothing but a glorified point system which has absolutely nothing to do with who i am, with my value as a human being. it saddens me how many people project their own inherent value onto the balance of their bank account - large or small.

[scoobynooby]

Your absolutely right. They buy up or make illegal and hide simple cures from the public and sell us death concoctions of left over industry chemicals like flouride and make money from it. When will Americans wake up? Oh yeah thats right Americans have been brushing with flouride for so long and are so addicted to entertainment they are too dumbed down and just dont have time to get educated and question Government. It's like a terrible nightmare these past 10 years.

[isis]

OMG. I take that drug. It makes me happy. I think.

[kellygrrrl]

so if the tainted toothpaste, toys and dog food don't get you, your allergy meds will.