The FDA will update the labels on 3 commercially-available leukotriene inhibitors to reflect post-marketing research findings that the asthma-fighters can precipitate neuropsychiatric events ranging from agitation to suicidal ideation.
Leukotrienes have become popular options for treating moderate to severe asthma.
They are usually used in conjunction with bronchodilators or inhaled steroid medications.
The new warnings will appear on the labels for Merk’s Singulair, AZ’s Accolate and Zyflo, which is made by Cornerstone Therapeutics.
Singulair dominates the category from a sales standpoint. First approved in 1998, the drug is Merck’s top revenue-producer with $4.3 billion in sales last year. The drug has been approved for both children and adults with asthma and for the treatment of certain allergies. The latter 2 are approved for asthma only.
Leukotrienes are produced by the body in response to inflammatory stimuli such as inhaled allergens.
“Patients and healthcare professionals should be aware of the potential for neuropsychiatric events with these medications,” read the posting on the FDA website.
Neuropsychiatric events that have been linked to leukotriene inhibitors include agitation, aggression, anxiousness, depression, hallucinations, dream abnormalities, insomnia, irritability, restlessness, suicidal ideation, suicide and tremor.
Merck released a statement saying it was “confident in the efficacy and safety of Singulair,” while adding it would revise the label as directed by the FDA.
Neuropsychiatric events other than sleep disorders and insomnia “were not commonly observed” in trial data provided by the drug makers, according to the FDA.
The FDA launched an investigation last year after receiving reports of mood and behavior changes in patients taking Singulair. It asked all 3 drug makers for all available post-marketing information, and made the call after completing that review.