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Zohydro Approval Brings Firestorm of Protest; State Bans

Debra Gordon

Last updated: October 20, 2016 7:49 pm

With the country in the throes of a prescription drug overdose epidemic – primarily of painkillers like Oxycodone—people everywhere are wondering why the Food and Drug Administration (FDA) went against its own committee’s recommendation and approved yet another long-acting opioid, Zohydro™ ER (hydrocodone bitartrate).

Long-acting opioids, while effective, carry a higher risk of overdose and death than shorter-acting painkillers like Vicodin. Not only that, but Zohydro contains up to 10 times as much pain reliever as any other narcotic on the market, enough, some critics say, for a single pill to kill a child and or for two to cause an overdose in someone unused to opioids.

It also has none of the safeguards that some other manufacturers have added to their long-acting products to make them harder to crush, dissolve, or otherwise tamper with to provide a quick high.

Zohydro, which the FDA approved in the fall, hit drugstores in March. It has drawn fury from state officials who are already grappling with high rates of opioid misuse, abuse, and addiction, as well as a flood of deaths from heroin overdoses, another, albeit illegal, narcotic. Last year, 28 states attorneys submitted a letter to the FDA asking it to reverse its approval of Zohydro or, at the very least, require that the manufacturer make it tamper resistant.

In late March, Massachusetts banned doctors from prescribing it and pharmacies from filling it, while Vermont now requires that doctors give patients an extensive evaluation and assess their risk for misuse and/or addiction before prescribing Zohydro. In Ohio, state legislators introduced a bill that would move the drug from a Schedule II designation – defined as drugs with a high potential for abuse with use potentially leading to severe psychological or physical dependence – to a schedule I designation, which means it is illegal and has no medical use. States have the power to regulate prescription drugs within their borders.

Meanwhile, two congressmen have introduced legislation that would require the FDA to rescind the drug’s approval.

After Massachusetts’ ban, the FDA issued a statement that “efforts by Congress and at the state level to legislate the approval or marketing withdrawal of medications are extremely troubling,” A few days later, FDA Commissioner Margaret Hamburg, MD, and Secretary of Health and Human Services Kathleen Sebalius issued another statement condemning painkiller abuse but, at the same time, highlighted the continued need for the development of safe, effective pain relievers. The announcement came the same day the FDA approved an autoinjector form of a drug designed to reverse opiod overdoses.


Stay tuned, though. . . there is still the possibility that the FDA will bow to the pressure and take the drug off the market.