US attorneys general from 28 states are asking the FDA to reverse its approval of the painkiller Zohydro. Signees, including AGs from Alaska, Arizona, Connecticut, New Hampshire, South Dakota and Tennessee, wrote to FDA Commissioner Margaret Hamburg, asking her to change the agency’s mind, or at the very least, create an expedited timeline that will require the manufacturer to create an abuse-deterrent version of the pain killer.
“We believe your approval of Zohydro ER 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 ten times more potent than traditional hydrocodone products, and it has no abuse-deterrent properties,” the attorneys general wrote in their Dec. 10 letter.
The medication created an uproar during the advisory panel review and after the agency’s October approval. The advisory panel voted 11-2 against the drug, and the Milwaukee Journal Sentinel and MedPage Today noted that a November 2012 FDA staff memo had anticipated that the drug would be more abused than traditional hydrocodone products.
The approval also followed report after report after report about rising opioid use and abuse, and even the FDA’s move in September to tighten painkiller labels.
The chief medical officer of the rehabilitation facility Phoenix House told Mother Jones after the FDA’s November 2013 approval that a key problem with the drug is that it “will almost certainly cause dependence in people that are intended to take it.”
The news runs in tandem with a Dec. 11 BioCentury report that the FDA accepted an NDA for a morphine/oxycodone medication for severe acute pain for MoxDuo IR by QRXPharma.
