On March 27 the FDA issued a safety alert regarding the asthma medication Singulair (montelukast). The alert was issued in order to inform healthcare professionals and patients about the agency's investigation into the possible link between Singulair use and depression and suicidality.
During clinical trials, depression was not reported as a side effect, however, drug makers are required to keep track of side effects reported to them after drugs go to market. During the past year, Merck & Co, Inc., which manufactures Singular, had received reports of tremor, depression, suicidality and anxiousness. In February of this year, Merck and the FDA began discussing how to disseminate this information to the public and the decision was made to interact face-to-face with prescribers and provide them with patient information leaflets to distribute.
The FDA is also working with Merck to review its study data as well as reviewing postmarketing reports. The FDA estimates that it will take about nine months to complete its investigation and the results will be released to the public once its review is complete.
At this time, it is not known whether there is a causal relationship between Singulair and depression and suicidality. Until further information is available, the FDA recommends that patients should not stop taking Singulair before discussing it with their doctor. It also recommends that healthcare professionals and caregivers should monitor patients taking Singulair for any suicidal thinking and behavior or changes in mood.
Singulair is a leukotriene receptor antagonist used to treat asthma and the symptoms of allergic rhinitis, and to prevent exercise-induced asthma.
The most up-to-date prescribing information for Singular can be found at http://www.singulair.com.
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