Learn More About Singulair Lawsuits
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Singulair (montelukast sodium) is a prescription medication approved to help control symptoms of asthma in adults and children 12 months of age and older. It is also prescribed for the relief of 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.
Singulair is taken once a day and dosage varies with the age of the patient. Singulair belongs to a class of drugs called leukotriene receptor antagonists. Leukotrienes are chemicals produced by the body in response to an inflammatory stimulus, such as an allergen.
Originally approved by the Food & Drug Administration (FDA) in 1998, Singulair was approved for the treatment of seasonal allergy symptoms in 2003. It can now be prescribed for patients with asthma and/or allergic rhinitis (sneezing and stuffy, runny or itching nose). Because more than 50 million Americans have nasal allergies, the expansion of FDA approval significantly increased sales as well.
Singulair was developed and is marketed by Merck & Co., a global pharmaceutical firm headquartered in Whitehouse Station, New Jersey. Singulair is Merck's biggest selling product and one of the world's top selling medications. In 2007, global sales of Singulair reached $4.3 billion—and most of those sales were in the Unites States.
In recent years Merck has regularly updated Singulair’s product information material to include information on emerging Singulair-related symptoms. These included tremors, depression and anxiety.
In August 2007, a 15-year-old high school athlete in upstate New York hung himself. The boy’s parents blame Singulair for his suicide. The FDA later required Merck to update the patient information material to include a warning about suicidal thoughts and behavior.
In March 2008, the FDA announced that it was investigating a possible link between the use of Singulair and suicide deaths and attempted suicides. Healthcare professionals and caregivers were advised to monitor patients taking Singulair for suicidal thinking and behavior and changes in behavior and mood.
Merck is cooperating with the FDA review, but has issued a statement that its own analysis of more than 11,000 patients in 40 clinical trials found no reported suicides or suicidal thoughts or behavior. It added that it was working to inform doctors about the concerns with Singulair.
In January 2009, the FDA announced that had not yet reached a definitive conclusion regarding Merck’s clinical trial data for Singulair. It concluded assessing data in June, but so far has found no definitive link between Singulair and suicide. The FDA added that it would communicate its findings and any resulting recommendations to the public at the conclusion of the review.
As of July, however, it reversed the initial assessment and required Merck to caution consumers about neurophysical side effects.
Read About The Risks Associated With Singulair
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