Adverse effects of montelukast examined by FDA's Pediatric Advisory Committee
Members vote for clearer warning labels advising physicians about risks of neuropsychiatric events.
PAC calls for clarity in labeling
Kenneth Towbin, MD, chair of the PAC and chief of clinical child and adolescent psychiatry at the National Institute of Mental Health, said there was a uniform wish among committee members for a way to get better information about the frequency of those events, although the committee had no recommendation on how to do that. He said the National Institutes of Health might be the place to think about the problem.
Googling on cell phones in the midst of the discussion, committee members got a different listing of precautions for the drug from reputable medical information sites, but there were references to possible mental effects on several of them.
The committee voted to recommend that the professional label should have the same kind of clarity as the consumer labeling; that the consumer labeling should have the reference to mental effects easier to see and higher in the list of things to be aware of; and that a letter should be sent to make healthcare providers aware of these changes.
Robert (Skip) Nelson, MD, PhD, deputy director of the FDA Office of Pediatric Therapeutics, said the FDA has jurisdiction over safety labeling. “We can work out what authority we have, but we will make every effort to do it,” he said.
The FDA Division of Pharmacovigilance recommended that it continue surveillance on adverse events and the committee agreed.
In May, the FDA Nonprescription Drugs Advisory Committee recommended that the FDA not allow Singulair to be sold over the counter because of fear that persons would not use it wisely.
During the September pediatric meeting, the committee also agreed with the FDA’s recommendations that it continue surveillance for adverse events for about 11 other pediatric drugs and devices.
The labeling and review information is on the FDA’s web page for the September 23, 2014, PAC meeting.