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).

[ad]

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

Popularity: 4% [?]