Another Controversy Over The FDA And Prescription Painkillers

What a difference a day makes. Last Thursday, the FDA recommended reclassifying commonly used prescription painkillers that contain hydrocodone, such as Vicodin, to a more restrictive ranking on the national law enforcement schedule. The move, which was a significant policy change, was widely hailed as a positive, if long overdue, step in attempting to curb the misuse and abuse of these medicines. The next day, however, the agency ignored the advice of its own advisory panel and approved the first opioid to contain only hydrocodone, a step that was quickly criticized by patient advocates. Why? 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 more potential for abuse and misuse. “If the FDA was really interested in protecting the public, they would have said ‘No thanks, we have too many people dying of opioids in this country to justify approving Zohydro,” David Juurlink, a physician and director of pharmacology and toxicology at the University of Toronto, tells The Milwaukee Journal-Sentinel and MedPage Today. “Minus the pesky acetaminophen, plus the crushability, it’s a disaster in the making.” "We're just going to kill more kids and then the FDA is going to come back and say, `oh, we made a mistake,'" Avi Israel of Buffalo, New York, tells the Associated Press. His son, Michael, committed suicide in 2011 while struggling with painkiller addiction and h...
Source: Pharmalot - Category: Pharma Commentators Authors: Source Type: blogs