Despite Merck's revision of Singulair's prescribing information to include reports of tremors, depression, suicide and anxiousness, a new study by the American Lung Association finds that patients taking Singulair (montelukast) are no more likely to suffer from depression or to have an increased risk of suicide.
The independent researchers re-analyzed previous data and report their findings in the next issue of the Journal of Allergy and Clinical Immunology, but the study wasn't actually designed to assess suicidal ideation or suicide risk.
FDA approved the drug over a decade ago to treat seasonal allergy symptoms and asthma, but announced last March that it had received reports of suicidal thoughts and suicide, as well as mood and behavior changes, in patients taking the drug.
Two of the researchers disclosed financial ties with big pharma: Norman Edelman, MD owns stock in Johnson & Johnson, while Janet Holbrook, PhD, MPH has received research funding from Astra-Zeneca and Takeda. The American Lung Association says it has a strict policy against endorsing any product.
This year, the FDA has been expanding its look into the role medications play in psychiatric disorders, and are broadening their search beyond the usual suspects--psychiatric drugs--and looking at medications for asthma, seizures and smoking cessation.