The FDA is reviewing Singulair post-marketing reports it has received, and has requested that Merck (the maker of Singulair) evaluate study data for more information about suicidality and suicide.
The FDA uses Early Communications to inform the public about its ongoing safety reviews of drugs, and does not mean it has reached a conclusion. The FDA anticipates that it may take up to nine months to complete the ongoing evaluations, due to the complexity of the analyses. The FDA will communicate its conclusions and recommendations to the public, when the review is completed.Over the past year, Merck has updated the prescribing and patient information for Singulair to include the following post-marketing adverse events: tremor (March 2007), depression (April 2007), suicidality, (October 2007), and anxiousness (February 2008).
Singulair is used to treat asthma and the symptoms of allergic rhinitis (sneezing, stuffy nose, runny nose, itching of the nose) and to prevent exercise-induced asthma. Singulair is approved to help control asthma in adults and children as young as 12 months, to help relieve the symptoms of outdoor allergies in adults and children as young as 2 years, and indoor allergies in adults and children as young as 6 months.
In a statement, Merck said its analysis of more than 11,000 patients in 40 clinical trials found no reported suicides or suicidal thoughts or behavior. George Philip, head of Merck's Singulair development program, said that suicide had only been reported to their company in post-marketing reports.
Merck declined to state the number of deaths reported, but said it was a very small number relative to the amount of people taking Singulair.
Merck plans to highlight the recent changes in the prescribing information in face-to-face interactions with prescribers and will provide prescribers with patient information leaflets about Singulair.
Singulair is Merck's biggest selling product and one of the world's top selling medicines with 2007 global sales of $4.3 billion, of which $3.4 billion in sales occurred in the Unites States.
Singulair is in a class of medications called leukotriene receptor antagonists (LTRAs), which work by blocking the action of substances (leukotrienes) in the body that cause the symptoms of asthma and allergic rhinitis.
The FDA is also reviewing post-marketing reports it has received of other leukotriene modifying medications including Accolate, Zyflo, and Zyflo CR and will assess whether further investigation is warranted.
The FDA said patients should not stop taking Singulair before talking to their doctor, and healthcare professionals should monitor patients taking Singulair for suicidality, until additional information is available.
By Jaime Jofre