Wednesday, October 28, 2009

Lost in Transmission — FDA Drug Information That Never Reaches Clinicians

This NEJM Article points out that, although, "Drug labels are written by drug companies, then negotiated and approved by the FDA," still, "information gets lost between FDA review and the approved label."

What often gets lost is data on harms due to the drug. Several examples are included, and it turns out that two popular drugs for insomnia actually didn't prevent patients using the drugs from having insomnia, although you wouldn't learn this from their labels. This article is an important read about drug labelling and drug regulation.

No comments: