An FDA staff scientist has reversed himself on an earlier opinion about a patch used to treat ADHD, telling an agency expert committee that the therapy from Shire Pharmaceuticals and Noven Pharmaceuticals should be approved. On Thursday, the FDA released a document saying the patch should not be approved because it increased the risk of side effects such as muscle twitches, anorexia and insomnia. But FDA staff reviewer Robert Levin says that he now thinks the therapy was not as risky as believed earlier. Risks remain, he added, but at a lower level.
- see this report from The San Diego Union Tribune for more information