US FDA concludes Singulair and other LRAs are not associated with suicide risk
After reviewing data from clinical trials, the US Food and Drug Administration has concluded that Merck & Co's asthma drug Singulair (montelukast) and related compounds are not associated with an increased risk of suicidal thoughts or behavior.
The US drug major's $4.3-billion a year product was first approved in 1998 and its patent does not expire until 2012. Two other approved medicines, Anglo-Swedish drug major AstraZeneca's Accolate (zafirlukast) and USA-based Critical Therapeutics' Zyflo (zileuton), belong to the same class and have also been cleared.
The agency began investigating the leukotriene receptor antagonists last year (Marketletter April 7, 2008). Merck's Singulair, as the number-one prescribed product in the US respiratory market, is the most widely-used member of this class.
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