FDA Probing Allergy Drug Suicide Risks

(CBS/AP)  The U.S. 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 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.

CBS News correspondent Kelly Wallace reports Kate Miller's 15-year-old son Cody killed himself just 17 days after starting the drug.

"It was the end of our world and we didn't know why, because this child was a perfectly normal healthy child, Never had a problem," Miller says.

His mom now believes that Singulair cost him his life.

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.

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.

Merck says the information is on the company's Web site, though one must go to the fourth page of a product labeling file to find it.

Dr. Mary Ann Michelis told CBS News she received calls from concerned patients Thursday. She's now writing letters to every patient who takes Singulair, urging them not to over-react.

Michelis said, "They should not stop taking their medication unless they are experiencing a major change in their moods."

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 U.S, according to Merck. First approved in 1998, it is 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.

Shares of Merck & Co. Inc. fell 16 cents to $44.54 in late trading.

[paulads-2009]

My 6 yr old daughter has been on this drug for over a year. She had a seizure Feb.9,2008 and nearly died. This new info on this drug explains alot. She has a prexisting condition but I believe this drug aggrivated her condition and have taken her off of it. We have had no further seizure activty either.My heart goes out to the Miller family that lost their son. My twins have a genetic disorder. I know what you are dealing with. I live with it every day.When they were born I was told that they probably wouldn''t live to be 5 yrs old and if so they would be retarded. I certainly don''t need to have to worry about every drug that I give them.

[matthewct1]

Read people''s Singulair horror stories here: http://www.medications.com/se/singulair. You won''t believe what you''re about to read.

[matthewct1]

THE SH&T IS REALLY HITTING THE FAN NOW MERCK IS SCREWED THIS IS ONE BAD DRUG FOR KIDS!!!!!!!!!!!!!!!!!MORE INFORMATION IS COMING OUT FROM PARENTS BY THE HOUR!!!!!!

[nenamatahari]

Wow! This really surprises me. I''ve been on Singulair for almost a year. And for that year I''ve been super depressed. Before then I never had the urge to cut myself, but now I do. I never acted on those urges. I was just confused by them.

I always research every drug I''m on, but there''s always something missing. :(

Geeze! You either die of asphyxiation from drowning in excessive mucous or asphyxiation from hanging yourself with your bathrobe belt.

My sympathy goes out to Cody''s parents. =( Suicide is an awful way to lose somebody.

[iknowbest-2009]

Posted by drinuk at 12:10 PM : Mar 28, 2008

To those with Asthma, stay away from the drugs. Check out the Hungarian Salt Pipe, it works. I have had the complaint for over sixty years and have had no success whatsoever with Big Pharma Junk. What does work is a careful diet avoiding the "Triggers" i.e. Coffee, Red Wine and all chemical additives. Learn about the Russian Breathing technique for Asthmatics, get rid of cats and dogs and buy a bagless cleaner.


Oh my God! Tom Cruise posts on this site! This is the funniest thing posted here year to date, outstanding! Of course, you forgot to mention that lining all the walls with tinfoil helps. "Hungarian Salt Pipe"??!!! That sounds like something you''d buy at an adults only store. Thanks for making our day, really priceless. Let me guess - you''re a liberal, right?

[matthewct1]

To justfacts2 who wrote:

"Funny, I am on Singulair and I have never had any of these symptoms. It is the best medicine I have taken that controls my asthma. Just because some people that take this medication are already having suicidal tendencies,that shouldn''''t mean they take the drug off the market. Those people need psychological help. Why is it so few morons ruin it for so many? "

I hope your lungs sieze up on you when they take this drug off the market. Check yourself...you''re not the center of the universe...callous child!

[terrisa3]

We are very interested in this story and request further information because we too have a similar situation with our 15 yr old. Depression, suicide attempt, leg cramps. So beyond the norm for our child and it began when she was given singular yet all over a length of 2yrs, not within days. Improvement was shown after taking her off from it. This would certainly explain alot of our questions if this drug was a factor.

[drinuk]

To those with Asthma, stay away from the drugs. Check out the Hungarian Salt Pipe, it works. I have had the complaint for over sixty years and have had no success whatsoever with Big Pharma Junk. What does work is a careful diet avoiding the "Triggers" i.e. Coffee, Red Wine and all chemical additives. Learn about the Russian Breathing technique for Asthmatics, get rid of cats and dogs and buy a bagless cleaner.

[drinuk]

Here we go again, The unfit for purpose FDA closing the gate after the event. Are not these corrupt cretins suppose to check this junk before it is placed on the market.

docadama3, You sound like a Big Pharma plant, don''t talk such c r a p ! The truth is that people inside the FDA are taking graft to get these poisons approved. Thankfully people are waking up, many of whom will be throwing ropes from large tree''s shortly, there are no shortage of candidates thats for sure. If the politicians won''t sort out these crooks the people will.

[jlstein1]

It is terrible when ever a child dies and i am sorry for your loss. i have been on singular for over a year along with other meds includung wellbiuton for depression who knows what came first. I also think any medications are going to have an effect on how you see yourself because you become dependent on it to function whether to breathe better or feel better