Monday, October 28, 2013
FDA Approves Pure Hydrocodone Drug
Last Friday, the Food and Drug Administration (FDA) approved Zohydro ER (extended release), the first pure hydrocodone drug in the United States, the Associated Press reports. Zohydro is meant for patients with chronic pain, those who require long-term treatment that cannot be treated with other drugs.
In December of 2012, the FDA voted against recommending approval of Zohydro ER, citing concerns over the potential for addiction. In an 11-2 vote against approval, panel members stated that despite the drug’s maker, Zogenix, meeting requirements for safety and efficacy, it was thought that Zohydro could be used by people addicted to other opioids.
The panel changed their vote after backlash from patient safety advocates, who criticized the FDA’s decision. “We’re just going to kill more kids and then the FDA is going to come back and say, ‘oh, we made a mistake,’” said Avi Israel, founder of a group combating painkiller abuse in young people.
Israel’s son Michael committed suicide after battling with painkiller addiction.
In a statement, the FDA noted, “Zohydro ER will offer prescribers an additional therapeutic option to treat pain, which is important because individual patients may respond differently to different opioids.”
It is clear that approval of the drug will open the door to more abuse cases, as well as a higher potential for overdose due to the higher strength of Zohydro when compared to Vicodin.