FDA: Certain asthma medications need new prescribing, side effects information

WHITEHOUSE STATION, N.J. The Food and Drug Administration has asked manufacturers of a class of asthma drugs to revise their prescribing information to include information about the possibility of psychiatric side effects.

The FDA cited reports of some people taking leukotriene modifiers experiencing mood and behavior changes. The drugs inhibit leukotrienes, chemicals that the body releases in response to such inflammatory stimuli as allergens and can lead to obstruction of the airways. The leukotriene modifiers Merck & Co.’s Singulair (montelukast), AstraZeneca’s Accolate (zafirlukast) and Cornerstone Therapeutics’ Zyflo (zileuton).

In response, Merck said it had updated the prescribing information for Singulair to include the psychiatric side effects the FDA cited, and that it would continue working with the agency to revise the prescribing information to include a precaution about them.