Friday, December 13, 2013

Attorneys General Want FDA to Reconsider Zohydro

Pat Enson, National Pain Report, December 11, 2013

Attorneys general from 29 states have asked the Food and Drug Administration to reconsider its recent approval of Zohydro, a powerful new extended release painkiller.

In a letter sent to FDA Commissioner Margaret Hamburg, the attorneys general said they did not want a repeat of the past when narcotic painkillers entered the market without tamper resistant formulas. Drug abusers learned they could crush or liquefy painkillers such as oxycodone to snort or inject the drug.

"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 letter says.

In October, the FDA ignored the advice of its own advisory panel, which voted to reject Zohydro because of its potential for abuse.

If approved and marketed, Zohydro ER will be abused, possibly at a rate greater than that of currently available hydrocodone combination products,” FDA staff reviewers wrote in a report.

You can read the full article at National Pain Report.

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