Attorneys General Want FDA To Rescind Painkiller Approval

Two months ago, the FDA caused a stir by ignoring the advice of its own advisory panel and approving the first opioid to contain only hydrocodone. The move was quickly criticized by patient advocates, because Zohydro ER is designed to be released slowly over a 12-hour period, but can be crushed, chewed or mixed with alcohol to provide a kick. In other words, there is potential for abuse and misuse. Ironically, the approval came just days after recommending that commonly used prescription painkillers that contain hydrocodone, such as Vicodin, should be reclassified to a more restrictive ranking on the national law enforcement schedule. The move was a significant policy change and was widely hailed as a positive, if long overdue, step in attempting to curb the misuse and abuse of these medicines. Now, though, a group of 28 state attorneys general have written to FDA commish Margaret Hamburg to ask that the agency either reconsider its decision or set “a rigorous timeline for Zohydro ER to be reformulated to be abuse-deterrent while working with other federal agencies to impose restrictions on how Zohydro ER can be marketed and prescribed,” their letter states (here is the letter). “We believe your approval… has the potential to exacerbate our nation’s prescription drug abuse epidemic because this drug will be the first hydrocodone-only opioid narcotic that is reportedly five to 10 times more potent than traditional hydrocodone products, and it has no abuse-deterrent p...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs