A Questionable FDA Decision on a New Painkiller
We had barely had time to enjoy our success with the FDA decision to reclassify hydrocodone combination products to Schedule II, when the FDA announced on October 25th the approval of the first-ever hydrocodone-only drug, Zohydro, a very dangerous drug. It is pure hydrocodone, and unlike Vicodin, Lortab and Norco it is not buffered with over the counter medications. This will be the first extended-release formulation of hydrocodone on the market, so each pill will be very potent. Also, Zohydro does not have an abuse-deterrent technology which the FDA has previously stated should be a requirement. Should the FDA be approving new narcotic painkillers while the epidemic of addiction and overdose death rages on? This decision is unconscionable. The FDA’s own advisory committee voted it down 11 to 2. Here is the positive spin being put on this decision by FDA: http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm372287.htm