New painkiller’s abuse potential is too high

The News TribuneApril 9, 2014 

Massachusetts Gov. Deval Patrick has ordered a ban on prescribing and dispensing Zohydro until it is marketed in a form that is difficult to abuse.

CHARLES KRUPA/THE ASSOCIATED PRESS

A new drug is just hitting the market, and it has local and state authorities wondering how soon they’ll start seeing the result: even more deaths associated with abuse of prescription painkillers.

Zohydro contains hydrocodone, one of a class of painkilling drugs that includes oxycodone and morphine — but it’s up to five times as strong as those more familiar painkillers. That makes Zohydro an extended-release alternative for patients who need relief from chronic pain for up to 12 hours per dose. It’s not tamper-resistant, however, so someone wanting to abuse it could chew, crush or dissolve it for a strong, quick high. Given its strength, that’s a prescription for a fatal overdose.

The Food and Drug Administration should never have approved this drug. Its own panel of medical experts voted 11-2 against approval, citing the potential for abuse and addiction.

States including Massachusetts and Vermont have moved to restrict or even prohibit doctors from prescribing Zohydro. Legislation has been introduced in the U.S. Senate that would force the FDA to withdraw its approval. And more than half of the nation’s state attorneys general — including Washington’s Bob Ferguson — asked the FDA to reconsider its decision.

It should. Although there’s apparently a need for this kind of extended-release painkiller, approval should wait until a tamper-resistant form of the drug is available. Until then, it would just be a more powerful version of opioids that are already addicting and even killing far too many Americans.

Deaths from prescription painkillers such as Oxycontin and Vicodin have risen dramatically since 1999 — more than 400 percent for women and 265 percent for men. Most of these are believed to be accidental overdoses, not suicides. According to the Drug Enforcement Administration, drugs containing hydrocodone rank among the most-abused medicines in the U.S. The increase in deaths is directly proportionate to the increase in the number of prescriptions.

Zogeniz, the manufacturer of Zohydro, says it will set up an oversight group of seven medical, addiction and law enforcement specialists to monitor whether the drug is being abused. But five of those experts have served as paid consultants for the company and will be compensated by Zogeniz for their work on the oversight panel. How independent can they be expected to be?

The FDA jumped the gun by approving this powerful new drug. If it doesn’t quickly withdraw that approval, Congress should move to ban it until a tamper-resistant version is formulated.

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