28 attorneys general say no to Zohydro

Share this article:

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.
Share this article:

Next Article in Business Briefs

Email Newsletters

More in Business Briefs

AstraZeneca takes on pediatricians

The American Academy of Pediatricians says an AstraZeneca drug for preemies should be used less often, and the drugmaker is fighting back with an ad campaign that says the new guidelines put too many at risk.

UK generic use soared in 2013

Generics made up almost 75% of prescriptions in the United Kingdom last year.

GSK refutes consumer spin-off rumor

The company refutes a Financial Times rumor that one was happening soonish.