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December 11, 2013

Miller, Attorneys General Question FDA's Approval of Powerful New Narcotic Painkiller

Zohydro is 5-10 times more powerful than hydrocodone, FDA did not require abuse safeguards

(DES MOINES, Iowa) Attorney General Tom Miller is urging the U.S. Food and Drug Administration to reconsider its approval of a powerful new narcotic painkiller, or require manufacturers to reformulate the drug to deter its abuse.

In a letter sent Tuesday to the FDA, Miller and a bipartisan group of 28 state and territorial attorneys general wrote that in approving the opioid analgesic Zohydro ER in October, the agency created “the potential to exacerbate our nation’s prescription drug abuse epidemic” because of the drug’s potency and lack of abuse-deterrent properties.  The FDA’s approval ran counter to a medical advisory board’s recommendation last December.

“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, an extended release opioid painkiller manufactured by Zogenix Inc. of San Diego, California, is made of pure hydrocodone.  According to the medical news publication MedPage Today, Zohydro “will come in doses packing five to 10 times more heroin-like narcotic than traditional hydrocodone products such as Vicodin.”  The drug is expected to be available beginning next year.

Opioids are a class of drugs that are similar to morphine and heroin.  Medications that fall within this class include hydrocodone (e.g., Vicodin), oxycodone (e.g., OxyContin, Percocet), morphine (e.g., Kadian, Avinza), codeine, and related drugs.

Without abuse-deterrent properties, like tamper-resistant pills with a gel-like consistency, abusers can chew the pills, or crush them to snort or inject.

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

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

In 2010 drug manufacturer Purdue Pharma introduced a tamper-resistant form of its best-selling painkiller OxyContin (oxycodone).  In November 2012, a study in the American Pain Society’s The Journal of Pain found that tamper-resistant extended-release oxycodone reduced the drug’s abuse by 41 percent.  Non-oral abuse dropped by 66 percent, and oral abuse dropped by 17 percent, according to the study.


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