West Virginia Senator Calls on Head of HHS to Overrule Decision on Zohydro

West Virginia Senator Joe Manchin this week called on Health and Human Services Secretary Kathleen Sebelius to overrule the Food and Drug Administration’s (FDA) decision to approve the pure hydrocodone drug Zohydro ER (extended release).

Fox News reports Manchin sent Sebelius a letter expressing his concern that Zohydro could add to the national epidemic of prescription drug abuse. “Given the potentially imminent release of Zohydro later this month, it is imperative that you act as soon as possible to keep this dangerous drug off the market,” he wrote.

Late last year, Manchin and three other senators wrote to the FDA, saying they disagreed with the agency’s decision to approve the drug. In October, the FDA approved Zohydro for patients with pain that requires daily, around-the-clock, long-term treatment that cannot be treated with other drugs. Drugs such as Vicodin contain a combination of hydrocodone and other painkillers such as acetaminophen.

In December, the attorneys general from 28 states asked the FDA to reassess its decision to approve Zohydro.

A panel of experts assembled by the FDA voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction. In the 11-2 vote against approval, the panel said that while the drug’s maker, Zogenix, had met narrow targets for safety and efficacy, the painkiller could be used by people addicted to other opioids, including oxycodone.

The agency will require postmarketing studies of Zohydro ER to evaluate the known serious risks of misuse, abuse, increased sensitivity to pain, addiction, overdose, and death associated with long-term use beyond 12 weeks.

Zohydro is designed to be released over time, and can be crushed and snorted by people seeking a strong, quick high. The opioid drug OxyContin has been reformulated to make it harder to crush or dissolve, but Zohydro does not include similar tamper-resistant features.