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Singulair FDA Warnings - Possible Connection to Suicidal Thoughts

Singulair, generically known as montelukast sodium, is a medication manufactured and distributed through the pharmeceutical conglomerate Merck and Co. It is used primarily for the prevention and control of asthma and related bronchoconstriction reactions, but has also seen wide use in the prevention and control of allergies related to similar symptoms. It is one of Merck's most popular drugs in several categories: sales, prescriptions, and revenue generated. According to Merck, it has millions of users across the United States, ranging in age from adults on a maintenance therapy regimen to young children preventing serious asthma reactions during particularly sensitive allergy seasons. It generated upwards of $3.6 billion for the company in 2007 in the United states - and more than $4.3 billion globally. It is Merck's best selling prescription medicine.

Recently, there have been reports of additional side effects not previously associated with the drug. In the last year alone, Merck has changed the language on the prescribing information four times to include information on a range of newly reported side effects: tremors, anxiousness, depression and suicidal behavior. None of these symptoms were initially listed on the medication, nor did they surface in the controlled studies Merck performed in an analysis of more than 11,000 patients in 40 clinical trials. However, several reports of suicidal thoughts and behaviors have surfaced recently in light of the drug's ongoing updated warnings.

In one case, a 5-year-old child repeatedly told his mother he "...didn't want to be in this life anymore..." and exhibited destructive and dangerous behavior toward himself and his family. More recently, television network NBC reported that a couple in New York are blaming their son's suicide on the medication. Previously, the 15-year-old had been taking another medication to control his allergies. However, just days after making the switch to Singulair, he took his own life. Both of these cases seem representative of other reports linked to the medication; the majority of them have no prior history of psychological problems and are generally healthy and well-adjusted individuals. It seems as if there is a strong link between the drug and these behaviors.

On March 27th, 2008, the FDA announced it was reviewing a possible connection between Singulair and suicidal behavior in adults and children, after receiving reports of mood and behavior changes, suicidal thinking and suicide in patients who took the drug. Additionally, when asked about the number of reports of these suicides linked to the drug, Merck declined comment, but said that they were present in both children and adults. In their announcement, the FDA recommended, "...until further information is available, healthcare professionals and caregivers should monitor patients taking Singulair for suicidality (suicidal thinking and behavior) and changes in behavior and mood."

As per the FDA's recommendations, it is strongly suggested that patients taking Singulair or parents who are concerned about potentially dangerous side effects of the medication should consult their primary care physician about their health concerns.

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