FDA Probing Allergy Drug Suicide Risks

Merck's Singulair Has Handful Of Reports Involving Mood Changes, Suicidal Behavior And Suicide

(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.

[david1737]

In the 2000 election pharma and oil were called the "Bush stocks" because their stock would rise and fall according to Bush''s poll numbers. The Presidential debates were sponsored by a company called "America''s Pharmaceuticals."

The Bush Admin. has handed big pharma the ability to choose profit over safety by allowing them fast track approval through the FDA.

This is deregulation at its worst. If you want more of the same vote for another Republican.

[Renegade.Rivers]

This is deregulation at its worst. If you want more of the same vote for another Republican.

Posted by david1737

--------------------------------------------------

Although I am not a Republican, I must point out that this is just plain bunk. Bills that have given big pharma the free reign that it now has, was supported and passed with the help of Democrats, and was not just a Republican act. Granted there are former board members of big pharma now in control of the FDA, but this was allowed to happen in no small part by the Democrats as well as Republicans.

[justfacts2]

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?

When people blindly accept any synthetic medication the Big Pharma has made and tested for profit with out seeking a natural alternative, then the consequences should not be a surprise.

[antoniof123]

Granted there are former board members of big pharma now in control of the FDA, but this was allowed to happen in no small part by the Democrats as well as Republicans.

Posted by renrivers at 03:49 PM : Mar 27, 2008

That is partly true, the only time the Democrats could have stopped and appointed person is if it when to the Senate for a vote and then the Democrats would have needed compelling evidence to stop it. They can not just say no to an appointment. Most people believe they can but a reason has to exist. Unless of course you are a Republican and you go around the law. But hey we have seen enough of that lately.

[rachetjaw813]

I am appalled by some of the comments made regarding Singulair. I am a mother of an 8 year boy that has been taking Singulair for almost 4 years now. Until now, I had no way of knowing how to deal with his bouts with sad days. He would always say to me, "mommy, I don''t know what is wrong". I was on the verge of getting some counseling for him. I received the email today regarding the investigation and I almost fell over and then I got angry. This has nothing to do with a DEM or a REP....this has everything to do with people not THROUGHLY investigating a drug that has caused so much devastation. It should have everything to do with the morals of the people doing the investigation. What if that was your child that killed him/her self. My son is my life and for him at such a tender age of 8 to experience DEPRESSION and relate it to "mommy i don''t know why i''m feeling this way"...angers me to the core. He should be feeling nothing but happiness/excitement/adventure that every 8 year boy/girl should be feeling.

[rachetjaw813]

I am appalled by some of the comments made regarding Singulair. I am a mother of an 8 year boy that has been taking Singulair for almost 4 years now. Until now, I had no way of knowing how to deal with his bouts with sad days. He would always say to me, "mommy, I don''t know what is wrong". I was on the verge of getting some counseling for him. I received the email today regarding the investigation and I almost fell over and then I got angry. This has nothing to do with a DEM or a REP....this has everything to do with people not THROUGHLY investigating a drug that has caused so much devastation. It should have everything to do with the morals of the people doing the investigation. What if that was your child that killed him/her self. My son is my life and for him at such a tender age of 8 to experience DEPRESSION and relate it to "mommy i don''t know why i''m feeling this way"...angers me to the core. He should be feeling nothing but happiness/excitement/adventure that every 8 year boy/girl should be feeling.

[rachetjaw813]

This has nothing to do with who the heck is in the White House, what status they hold...it should have everything to with following all the steps/investigation that it takes to make sure drugs are safe for all ages.. It shouldn''t take all this time to find out the drugs we are taking that are suppose to make us live productive and happy lives are causing us pain and devastation. It doesn''t start at the top it starts at the bottom and goes up. I hope the answers will be revealed soon and that every parent that has a child on Singulair STOPS the medication immediately. Don''t wait. You know your child better than any doctor does....my son had his last dose last night and will not take another pill..

[prinzowhales]

The mass murderers at Merck have yet to be prosecuted and jailed for the killing tens of thousands of Americans with Vioxx...

Find what is causing your asthma and deal with it...just don''t mask the symptoms with garbage drugs from Big Pharma...

[barbaraf4]

Once again we have a drug that supposedly went through testing and was unleashed on the general popularion. Now we find out that maybe it shouldn''t have been released without further testing. This seems to be happening more and more frequently.

Listen up everyone: Pharmaceutical companies are NOT in the business of curing what ails you. Pharmaceutical companies are in the business of picking your pocket.

[docadams3]

People should know that asthma itself is a known risk for suicide. This has been researched and documented for more than 20 years. That suicide would be associated with an asthma medication is not very surprising.

[kenmar71]

I''ve been taking it for 6 years and I haven''t killed myself yet.

[taylpatr]

The actions of the politicians who have helped to de-regulate the pharm. industry are to blame. Whether repug or demogog, somebody somewhere has had their coffers filled at our expense. The pharm. lobby is one of the most powerful there is; witness their advertisments on television. If that''s not pushing drugs, what is?

[cyinzl8r]

Yea, Thats right, the heads of these drug companies get together with Bush and Cheney and decide to produce a drug that kills the people who take it. They do it because it makes sales and profits go up when you kill off your customers. It all makes perfect sense. You conspiracy theorists need to get off of it. It''s a ridicules notion that they want to kill people on purpose. This country leads the world in Drug R&D and medical procedures. Be proud of the US. Stop bashing it. You are losing credibility with your hate of the current administration and this country. If you don''t like it, then move. You give our enemies hope that their efforts are fruitful. Stop fueling their attacks, they will eventually go away if we do not pay attention to them. sieg heil my a_s_s

[jdbrooke]

I would like to commend Merck for taking a proactive approach to this touchy subject. I wish bad publicity was the effect of companies trying to do the right thing.

[quetzal0666]

Good God, the way things are going
eventually even eating out will lead to suicide..

[panhandlpete]

If only people would use THEIR brainpower and think for themselves, but "NO" they believe everything they are told by others....even the drug companies and the FDA. Just because a drug is classified as safe to be put on the market does not mean all the side effects are known at that time. The testing is done under controlled situations and generally with selected subjects who will give positive results. Then, when it goes out to the masses, who live varying life styles which may include other drugs, many different problems may arise.

So, if you care about your own body and your family members, do research on ANY drug before you put it in your system. If you can live without taking drugs, you might live better and longer. We are a society that takes pills to wake up, go to sleep, and for every possible little ache and pain. Sit in a DR''s waiting room for about two hours and watch for the Mfg DRUG REP.....then you might be able to evaluate for yourself why YOUR doctor pushes drugs.......he/she wants to win that island vacation or whatever is being offered. Is this bribery or pay-offs?

[iknowbest-2009]

Another Federal agency corrupt and inefficient under the RepubliKKKans? What a shocker.

[matthewct1]

READ THIS.......
My 5 year old son was diagnosed with mild asthma and put on Singulair. Within a few months he began having uncontrollable fits of rage, displayed self-loathing behavior, had night terrors, and was inconsolable during these episodes. He became very destructive and was a danger to himself and our family. He even talked about killing himself and would say things like "I don''t want to be in this life anymore" and "I want to kill myself". He would threaten my wife and his siblings and told them he wanted to kill them. It was a truly terrifying experience. Our pediatrician was clueless to these side affects and recommended we have our child go through a psychological evaluation. I knew this was not my child''s normal behavior so I searched the internet for Singulair side affects and found some message boards where parents just like myself were telling their stories of their children''s agressive behavior. I immediately took my son off the drug and within a couple days he was back to his normal self. He told us that he no longer has "that feeling inside of him". Five year old children don''t even know what suicide is and to see my son talk like this was extremely frightening.

Merck has a serious problem with this drug and while not everyone is going to experience these same side affects, they are real and there is no doubt in my mind we will see this drug taken off the market after the FDA performs it''s investigation. BEWARE!!!!!!

[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

[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.

[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.

[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.

[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!

[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?

[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.

[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!!!!!!

[matthewct1]

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

[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.