Singulair suicide side effects to be reviewed by FDA

The FDA has released a statement regarding their investigation into a possible association between Singulair and suicides, suicidal thinking and unusual behavior changes. The drug regulators have requested additional information from Merck & Co., the manufacturer of the popular asthma medication, and they expect to complete their evaluation of the Singulair suicide side effects within the next nine months.

>>FDA Early Communication: Singulair Suicide Investigation

Singulair is a pill approved by the FDA for treatment of asthma and allergy symptoms. The medication works by controlling chemicals that are released during allergic reactions which may lead to inflammation, congestion and other allergy symptoms. In recent years, it has become one of the best selling medications in the world, with total sales of $4.3 billion in 2007, about three quarters of which came from prescriptions in the United States.

Since last October, the FDA has received several reports of suicide among users of Singulair, as well as other reports involving severe mood changes and suicidal behavior. Within the past year, Merck has added indications to the prescribing information about Singulair side effects which indicate that the drug could be associated with tremors, depression, suicidal thinking and anxiousness.

The FDA has requested Merck go back through adverse event reports received by the pharmaceutical company to take a closer look at the data. The agency will review available information to look for reports of behavior and mood changes, suicidal thoughts and suicides among Singulair users. After they have completed their review, the FDA will communicate any conclusions and recommendations to the public. This could include stronger warnings, restrictions on who can receive the medication or no regulatory actions at all.

Singulair is part of a class of medications known as leukotriene agents, and other similar medications in this class include Accolate (manufactured by AstraZeneca) and Zyflo (manufactured by Critical Therapeutics). As part of their review, the FDA will evaluate whether any suicide risk with Singulair may also be associated with Accolate, Zyflo and Zyflo CR. However, those medications have been taken by a very small number of people when compared to those who have been prescribed Singulair. The combined sales of these other medications in the U.S. was under $70 million last year, compared to $3.4 billion for Singulair sales in the U.S.

While the FDA continues their investigation of the Singulair suicide side effects, they have cautioned doctors to carefully monitor patients taking the drug for mood changes and signs of suicidal thoughts. The FDA has indicated that the early communication does not mean that there is definitely a relationship between Singulair side effects and suicides, but reports received have led the agency to take a closer look at this emerging safety issue. There is no indication that users should stop taking the medicine, and no prescription drug should be discontinued without first speaking with your doctor.

SINGULAIR SUICIDE LAWSUITS

The lawyers at Saiontz, Kirk & Miles, P.A. are closely monitoring the FDA’s investigation into the possible Singulair suicide side effects. If you, a friend or family member have suffered severe physical injury or death as a result of a suicide or suicide attempt while taking Singulair, review the legal options which may be available by requesting a free consultation.

11 Responses to:

“Singulair suicide side effects to be reviewed by FDA”

  1. Angi Says:

    Our 10 year old son was diagnosed with an anxiety disorder by a psychologist pursuant to taking Singulair and we can document the connection. I am a civil litigation assistant for a small firm in Iowa and would be willing to serve as a lead plaintiff should there be any action pursued against Merck for failing to disclose the potential side effects of Singulair.

  2. Candice Says:

    I have not had physical harm or died because of Singuliar, but while I was taking the drug for my asthma I had mood swings and was not an easy person to get along with. Which effected my school and home life with my parents.

  3. Brian Says:

    My brother was on Singulair from June of 2002 until his suicide in June of 2004. Fine one day, and gone the next.

  4. Brandon Says:

    I think you all need to stop jumping to conclusions with baseless lawsuits.
    In clinical trials, only 1 patient attempted suicide in the singulair group, whereas 3 patients did so in other asthma medicine groups. This was studying over 44,000 people in each group.
    So just maybe, the suicide had to do with the person and not the drug. Sometimes people need to own up to what they did and not seek to blame it on anyone they can for a cheap buck.

  5. Derrick Says:

    I was an easy going person who was really easy to get along with and always relaxed before starting on Singulair. Afterwards I became a depressed monster with violent uncontrollable mood swings, I would cry during any and all arguments that I had, I thought life was completely hopeless, and put a gun to my head on several occasions contemplating blowing my head off and ending it all. My wife told me something was happening that was changing me because she knew that this behavior just was not me and I even starting seeking counseling for it. Luckily my wife was there to snatch the gun away from me and hide it whenever it got really bad. I treated my wife and my children so bad and now I’ve lost them. I’m off of the singulair now and starting to feel like my old self again but it’s too late for my family. My wife understands that this medication is likely to blame for this but says although she loves me very much, she just can’t get past the way i was on singlair. My life has been ruined and I’ve lost the most wonderful woman, beautiful daughters, my job, and my house is currently in foreclosure. I had to lose all of this just so that I could breathe a little easier?! Thank you Singulair! Thank you so much!

  6. John Says:

    In February 2008 I was prescribed Singulair. I started to get mood swings and a deep depression. I was getting ready to go to the doctors and say I have a problem and I may need to take something to help stop this. It was then I saw the news report. I stopped taking the Singulair. I went through and I am still going through horrible withdrawals from this medication.
    I already suffer with panic attacks and this has been amplified by my ordeal with this medication. The doctor who prescribed it has never called to see how I am doing. I have told my regular doctor about the problems I have had with this medication, I have even told the hospital and yet no one has helped me with getting off of it. I have stopped taking it slowly. On Monday April 7, 2008 I was going to take another dose to help but my withdrawals from the previous dose were so bad, I chose to ride it out.
    On Wednesday April 9, 2008 I passed out at the stove burning my hair and getting a mild concussion. On Thursday April 10, 2008 a panic attack turned into a run with another injury causing more to the concussion and a bruise over the right eye. I don’t know the relation of these episodes and the Singulair. I am still having the cold sweats, the nausea, the depression and mood swings from this drug. My sedative is what I take to help keep me calm.
    This is a horrible medication. Not only should MERC be held accountable but also the FDA and those doctors to arrogant to do their own research.
    Medication that are tested properly are good for us. Those that are sent out just for profit, that is when those who send it out need to be held accountable.
    We are not guinea pigs, we are human beings. I for one am tired of being messed with by a corrupt, uncaring and greedy system.

  7. patricia Says:

    I have been on this medication for 7 years and my quality of life has completely changed. I went from being a productive person to just a severely depressed, moody, having tremers, shakes the whole nine. I spoke with the doctor and we are asessing the issue.

  8. michelle Says:

    My 8 year old daughter has been taking singulair for 4 years due to allergies and asthmatic syptoms. She has been diagnosed by a psychologist with anxiety and depression. She also has alot of “mood swings” for an 8 year old. If Merck and Co. knew about this and let peditricians prescribe this i will fight to the end!!! I have taken her off of the medication, and i am hoping to see an improvement.

  9. Galen Says:

    i joke with my girlfriend calling singulair “my angry medicine,” she doesn’t think it’s very funny though. about a half hour after swallowing the pill, i am more angry and more irritated than ever for absolutely no reason. i’m typically a very calm guy but this medicine makes makes my mood very mad, i just can’t control the anger i feel, i never feel or have every felt that way except when taking singulair. i have been taking it for about a year but only once or twice a week (when i get stuck being around animals) the asthma relief it offers is good but the psychological effects are horrible. i couldn’t imagine taking this medicine everyday. i’m sure it screwed a lot of people up for life. it must take a huge toll on body and mind.

  10. Bertha Says:

    My son is 11 years old and has been on the adult dose of singulair since 2005 and just until recently after hearing of the side effects of Singulair was I able to connect his severe anxiety and depression to the medication. He has suffered for over two years and continued to take Singulair for his asthma and allergies even after I asked his doctors if there was any link after he started showing symtoms of anxiety and depression at the age of 9. My son has been off the medication for two weeks now and is somewhat better. He has not expressed the thoughts of hurting himself, wanting to die, or has sudden bursts of crying for no reason, or nightmares. I am also willing to attest to what kind of horror is has caused my son as well as my family for the past couple of years. I just hope that he does not continue to live with anxiety, fear and depression for the rest of his life.

  11. lynne Says:

    My 14 yr old son was on singulair for three and a half years,after two months on singulair anxiety and saddness set in,a year and a half on singulair severe depression to the point he was hospitalized,lexapro wellbutrin celexa all useless against it.A complete withdraw from society,only home schooling as he could not survive the pressures of life,two months off singulair and my happy boy is back but the life he lost irreplacble.

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