Notwithstanding the ongoing debate as to whether ADHD drugs are overprescribed because bored docs and overwhelmed teachers are overdiagnosing the disorder in children, it seems as the FDA once in a while actually serves the public purpose for which it was intended.
A patch developed to treat attention deficit hyperactivity disorder in children received a negative review from a Food and Drug Administration scientist, who concluded the drug cannot be safely marketed.
The patch uses methylphenidate, the same drug that is in Ritalin. But FDA reviewer Dr. Robert Levin found the patch produces troubling side effects too often to be considered safe. His findings were in briefing documents released by the agency on Thursday in advance of a public meeting on the drug.
The reviewer’s findings are not the final word. An independent panel of experts convened by the FDA is expected to consider on Friday whether the patch is effective and safe. The FDA has the final call on whether the patch can be made available, but the agency often follows the advice of its panels.
If only more drugs received this kind of critical review, I’d think some pharmaceutical companies wouldn’t be facing so many lawsuits these days.