Does Singulair Have a Black Box Warning?

At this time, Singulair does not have a black box warning attached to it. However, there have been some concerns raised that taking Singulair may cause some people to have anxiety, depression and changes in mood and behavior that can lead to suicide. Merck & Co., the makers of Singulair, voluntarily reported this and will be studying this matter more closely in an effort to determine if there really is a link between Singulair and suicide. However, the FDA has ruled that the risk is not great enough at this point to require a black box warning or take the drug off the market, though the risk of suicide was added to Singulair's labeling.

A joint statement by the American Academy of Allergy Asthma & Immunology (AAAAI) and the American College of Allergy, Asthma & Immunology (ACAAI) states that there is "no data from well-designed studies to indicate a link between Singulair and suicide. The concern expressed by the FDA is based entirely on case reports, and there is no indication that such effects apply to other leukotriene-modifying medications." They go on to recommend that people with asthma and allergies continue to take Singulair as prescribed, provided:

• Both you and your doctor feel the medication is effective for you.
• You are not having any suicidal behavior or thoughts.

If you or your child are taking Singulair, you should not stop taking it before talking to your doctor. But, do be on the watch for any signs of mood changes or suicidal thinking, and notify your doctor right away if you see or experience them.

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