The FDA requested that the labelling for leukotriene modifiers be updated to include a precaution about the potential for neuropsychiatric events in patients taking the asthma drugs. The request follows the agency’s review of such events, which have been reported in some patients taking Merck & Co.’s Singulair (montelukast), AstraZeneca’s Accolate (zafirlukast) and Cornerstone Therapeutics’ Zyflo and Zyflo CR (zileuton).

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In its safety update, the FDA noted that the side effects associated with the asthma drugs include agitation, aggression, suicidal behaviour, depression, insomnia and irritability.

In response to the request, Merck stated that Singulair’s label already contains post-marketing information about the neuropsychiatric events addressed in the agency’s communication, and added that it “will continue to work with the FDA to revise the prescribing information for Singulair in the US to include a precaution related to those events.”

Source: FirstWord

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In an updated safety review posted to the FDA website Tuesday, the agency said that it “has not yet reached a definitive conclusion regarding the clinical trial data on mood and behavioural adverse events associated with” Merck & Co.’s asthma drug Singulair (montelukast), as well as similar medications including AstraZeneca’s Accolate (zafirlukast) and Cornerstone Therapeutics’ Zyflo (zileuton). The agency anticipates that the ongoing assessments might take up to nine months to complete.

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The agency statement follows the announcement in March 2008 of a safety review investigating a possible link between Singulair and suicidal behaviour. The FDA indicated that Merck submitted data from 41 placebo-controlled clinical studies including 9929 patients who received Singulair and 7780 who took a placebo. Among the patients treated with the drug, one had suicidal thoughts and there were no completed suicides.

The FDA also noted that AstraZeneca submitted results from 45 placebo-controlled clinical trials conducted with 7540 patients treated with Accolate and 4659 who received a placebo, and no patients on the drug reported any suicidal behaviour. Regarding the data submitted by Cornerstone, the FDA said that the data did not show any suicidal behaviour in the Zyflo- treated patients. However, US regulators said that the clinical study data reviewed for suicide risk “were not designed specifically to examine” neuropsychiatric events, adding that “as a result, some events may not have been reported.”

In response to the review, Merck stated that the company “stands by the proven efficacy and safety of Singulair,” noting that “after a thorough review of the data from the controlled clinical trials of Singulair, and a careful assessment of post-marketing adverse events, Merck believes that the data support the continued use of Singulair in appropriate patients with asthma and allergic rhinitis.”

Source: FirstWord

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