Darned if I do, and darned if I don’t

Great. Just when I thought that I figured out why I am depressed, I get this in my email box from the FDA. I’m on Singulair because of my asthma. I wonder what Philip at Furious Seasons would say.

Suicidality and Behavior/Mood Changes with Singulair

Singulair (montelukast sodium) is approved to treat asthma and symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of nose), and to prevent exercise-induced asthma. Singulair is part of a class of “anti-leukotriene” drugs. These drugs act by blocking the activity of leukotrienes, chemicals that are involved in airway inflammation.

In the past year, Merck & Company, Inc. has updated the patient information for Singulair to include these postmarketing adverse events: tremor, depression, suicidal thinking and behavior (including suicide), and anxiousness.

In March 2008, FDA issued an early communication about an ongoing safety review of Singulair. The agency is investigating a possible association between the use of Singulair and behavior/mood changes, suicidal thinking and behavior, and suicide.

Early communications are in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. An early communication does not mean that FDA has concluded that there is a causal relationship between the drug and the emerging safety issue. It means that FDA is considering the information but has not yet reached a conclusion.

FDA is working with Merck to perform a complex analysis of Singulair data and will communicate the conclusions and recommendations to the public. The agency is also reviewing postmarketing reports it has received of behavior/mood changes, suicidal thinking, and suicide in patients who have taken Singulair as well as other leukotriene modifying medications, such as Accolate (zafirlukast) and Zyflo (zileuton) and Zyflo CR.

Advice for patients …
Patients should not stop taking these medications before talking to their health care professional about this information. FDA urges patients to report side effects from use of these medications to FDA’s MedWatch Adverse Event Reporting Program at: http://www.fda.gov/medwatch/report/consumer/consumer.htm

The Early Communication About an Ongoing Safety Review of Montelukast (Singulair) may be found at: www.fda.gov/cder/drug/early_comm/montelukast.htm

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4 responses

  1. I don’t think we all need to throw away our Singulair because of a few reports. I’ve taken Singulair for years. I noticed no effect on my depression. Remember everyone responds to meds differently. I’d talk to your doc if you are worried. Take care!
    etta

  2. this could totally be true… i was in a serious suicidal depression for like a year.. i always attributed it to finding out three years after the fact that the only guy i have ever really loved in this life had died of a heroin overdose in 2004,, and i am sure that contributed to it in a large way,,,

    but now that you mention it,, i was on singlair the whole time,, and now that i am off it,, since i cannot afford it and have no insurance,, the light at the end of the tunnel is truly becoming visible… this is the first i have heard of it,, but this is very possible…

    now it wasn’t a full blown suicidal episode,, but rather an agreement to die,, very logical and unemotional kind of thing… what about you????

    wow.. this kind of freaks me out …

  3. That’s a load of B.S. GAH! Everyone reacts differently and it does seem like something to investigate; it infuriates me that they are just finding this out now! “Oh, and btw, you might have feelings of killing yourself” in small print! Knowing this info first, would you have taken it to begin with? I think not, there are other asthma meds….

  4. @ everyone- Thank you all!! I will say that now I’m a bit more… what’s the word… paranoid about my meds since now I’m on new ones. I swear I should have gone to pharmacy school just to understand it all. But heck, even the doctors don’t get it, either.

    You are all right- everyone reacts to medicine differently. I am just jumpy about research.

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