Bipartisan coalition of 29 AGs question FDA approval of new painkiller

By Bryan Cohen | Dec 12, 2013

DES MOINES, Iowa (Legal Newsline) - Iowa Attorney General Tom Miller has joined 28 other attorneys general in a letter urging the U.S. Food and Drug Administration to reconsider the approval of a powerful new narcotic painkiller.

Miller and 28 other state and territorial attorneys general wrote that by approving Zohydro ER, a new opioid analgesic, the FDA created the potential to worsen U.S. prescription drug abuse problems due to the drug's potency and lack of abuse-deterrent properties. When the FDA approved the drug in October, it ran counter to a medical advisory board's earlier recommendation.

"People understand the need for effective painkillers, but it doesn't make sense that the FDA would approve such a potent narcotic like this without safeguards to stop its abuse," Miller said. "I'm very concerned that it's just a matter of time before tragedies occur when people abuse this prescription painkiller."

Zohydro ER, which is manufactured by the San Diego-based Zogenix Inc., is made of pure hydrocodone. Because the pills are not tamper-resistant, prescription drug abusers can chew the pills or crush them to inject or snort.

In March, Miller and other state attorneys general sent a letter to the FDA urging the agency to require opioid painkiller manufacturers to develop tamper-resistant generic versions of their prescription drugs.

Between 1999 and 2010, the number of U.S. drug poisoning deaths involving opioid analgesics more than quadrupled to nearly 17,000, according to the U.S. Centers for Disease Control and Prevention.

A November 2012 study in The Journal of Pain found that tamper-resistant, extended-release oxycodone reduced abuse of the drug by 41 percent.


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