The Food and Drug Administration is probing a possible connection between Singulair, which is Merck & Co Inc’s blockbuster asthma drug, and suicidal behavior in adults and children. The agency is reviewing the issue after receiving reports of mood and behavior changes, suicidal thinking and suicide in patients who took the drug. Singulair is used to treat allergy symptoms as well as asthma. Thus far no definite link to the drug has been established, according to the reports. However, the FDA hasn’t disclosed how many post-marketing reports it had received and Merck apparently won’t say how many reports had been submitted. The company did tell Reuters the reports did involve both adults and children. The behavioral risk is noted on Singulair’s drug label. The FDA has asked the company to evaluate its data for more information. The review is expected to take up to nine months to complete.
The FDA approved Singular in the United Stated in 1998. Merck claims that its analysis of more than 11,000 patients in 40 clinical trials found no reported suicides or suicidal thoughts or behavior. Merck says it was working to inform doctors about the concerns. The FDA is also reviewing reports of behavioral changes in patients taking similar drugs, including AstraZeneca Plc’s Accolate and Critical Therapeutics Zyflo. All three drugs are known as leukotriene agents that work by controlling leukotrienes — chemicals in the body that are released during an allergic reaction and can lead to inflammation, congestion and other symptoms.
Singulair is Merck’s biggest selling product and one of the world’s top selling medicines with 2007 global sales of $4.3 billion — $3.4 billion in the Unites States – which makes it a blockbuster drug. In comparison, Accolate took in $57.4 million in U.S. sales in 2007, while Zyflo and Zyflo CR combined brought in about $10 million, according to data from IMS Health. Those changes highlighted the risk of tremors, depression, anxiety and suicidal behavior on Singulair’s label. The FDA has urged patients to talk to their doctors. The agency wants healthcare professionals and caregivers to monitor patients taking Singulair for suicidal thinking and behavior as well as changes in behavior and mood.
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