FDA wants some allergy and asthma drugs to come with a new warning of potential psychiatric problems. In an announcement Friday, the agency said it had asked drugmakers to add cautionary language to the labels of Singulair (Merck), Accolate (AstraZeneca), and Zyflo/Zyflo CR (Cornerstone Therapeutics). Not as serious as an actual "warning," the precaution would disclose post-marketing reports of psych problems, some of them severe.
In clinical trials of the drugs, known as leukotrine modifiers, psychiatric side effects were uncommon, FDA said. But the studies weren't designed to evaluate psych issues, so the data are limited the agency said. Post-approval, the agency has received reports of psychiatric problems--from agitation and aggression to suicidal thinking and even suicide. Some of the reports "included clinical details consistent with a drug-induced effect," the FDA noted in its statement.
Responding to the FDA request, Merck said it has already included psychiatric side-effect reports in the post-marketing section of Singulair's label. But the drugmaker said it would work with the FDA to include a precaution about those risks.
- read the FDA release
- check out Merck's response
- see the story from Reuters