More black box warnings on the way
Black box warnings are the FDA’s strongest measure to inform physicians and consumers of a drug’s potential dangers. They seem to be getting more popular. Yesterday, an FDA advisory committee recommended adding black box warnings to ADHD drugs. They would warn of risks for heart attacks, stroke, and sudden death –a pretty high price to pay to get Johnny to conform to school norms. I’ve discussed this topic in the past and have noted the potential side effects, but frankly I’m surprised to see things move so quickly.
The vote was close, reflecting the split among clinicians and researchers in the field. If the FDA does follow through with the warning labels it will provide parents who don’t want to medicate their kids but who are pressured into it (often by their schools) with some powerful ammunition. But I wonder if this is really the best way to address the issue.
The panel was unanimous in recommending that the drug makers include a medication guide with their products that parents and patients could use.
See MedPage Today for more.February 10, 2006