Attorneys General of 28 States Urge FDA to Reassess Zohydro Approval

The attorneys general from 28 states are asking the Food and Drug Administration (FDA) to reassess its decision to approve Zohydro ER (extended release), a pure form of the painkiller hydrocodone. Earlier this month, four U.S. senators told the FDA Commissioner Margaret Hamburg they disagree with the agency’s decision to approve the drug.

In a letter to Commissioner Hamburg, the attorneys general said they believe the 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 said they hope the FDA either reconsiders its approval of the drug, or sets a rigorous timeline for Zohydro ER to be reformulated to be abuse-deterrent while working with other federal agencies to impose restrictions on how the drug can be marketed and prescribed.

The FDA approved Zohydro ER in October 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, the Milwaukee Journal Sentinel reports.

In December 2012, a panel of experts assembled by the FDA voted against recommending approval of Zohydro ER. The panel cited concerns over the potential for addiction.

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.

Kentucky Attorney General Jack Conway said in a news release, “Zohydro ER has the potential to exacerbate the prescription pill epidemic and given that abuse-deterrent properties are capable of being developed and required, the FDA’s decision to approve the drug doesn’t make sense.”