
Although Singulair’s drug label indicated the possible behavioral risk, the FDA asked Merck to evaluate its data in order to obtain more information regarding the situation. This could take up to nine months.
In a previous study regarding the drug, where 11,000 participants in 40 clinical trials, no one reported suicidal thoughts and no suicides were reported.
Similar drugs are also being reviewed including AstraZeneca Okc’s Accolate and Critical Therapeutics Inc’s Zyflo but to date no investigation is needed. These drugs, and including Singulair, are considered leukotrienes and work by controlling leukotrienes which are chemicals in the body that are released when someone has an allergic reaction. Allergies can lead to inflammation, congestion and other symptoms that are controlled by these popular drugs.
Singulair brought in over 4.3 billion dollars globally in 2007 alone.
There is no need to reduce the use of Singulair to date, note analysts, but label changes have been done including highlighting the risk of tremors, depression, anxiousness and the now noted suicidal behavior. Patients using any of these drugs are being urged to consult with their healthcare professional and to have someone monitor them for suicidal thoughts and behavior and any other changes in behavior.
[Source: YahooNews]






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