'Unprecedented': Legislators Are Trying To Ban A Dangerous New Painkiller Approved By The FDA


Joe Manchin


Sen. Joe Manchin, D-W.Va., has introduced a bill that would withdraw the FDA's approval of Zohydro.

Some lawmakers are hurrying to ban a potent new painkiller that caused an uproar when it was approved by the Food and Drug Administration against the recommendation of an expert advisory committee.


Massachusetts is the first state that has succeeded in blocking sales of new pain pill Zohydro, and legislators in Congress are trying to revoke the FDA's approval of the drug.

Last month, Gov. Deval Patrick declared a public health emergency in light of a recent spate of opiate overdoses in the state. Patrick doesn't want Zohydro sold in Massachusetts until drugmaker Zogenix releases it in a tamper-resistant form that would make it harder to abuse.

In a statement to Reuters, Zogenix said the Massachusetts ban "only serves to unfairly restrict patient access" and will "add to patient suffering in the state."

Zohydro is being marketed as a way to treat chronic pain. The pills pack a dose of hydrocodone that's five to 10 times higher than Vicodin, and experts worry that the drug could be deadly and lead to another spike in opioid addiction.


Hydrocodone has effects that are similar to heroin. Zohydro pills could be appealing to addicts and opioid abusers looking for a quick and dramatic high that comes from crushing or chewing the pill to release all the hydrocodone at once.

Currently, the pills are not made with tamper-resistant technology that would help prevent abuse. Zogenix is working on a tamper-resistant version of the drug, but it might not be available until the end of 2016, according to Bloomberg.

New England is in the midst of a nasty heroin epidemic, but Massachusetts isn't the only state that's concerned about Zohydro.

Legislators in Kentucky, West Virginia, and Massachusetts have also introduced bills in the U.S. House of Representatives and the Senate that would withdraw the FDA's approval of Zohydro.

Sen. Joe Manchin (D-W.Va.) (whose daughter is the CEO of competing drug company Mylan Inc., a major campaign contributor) and Reps. Hal Rogers (D-Ky.) and Stephen Lynch (D-Mass.), co-chairmen of the Congressional Caucus on Prescription Drug Abuse, introduced the legislation last month.


"In southern and eastern Kentucky, we lost nearly an entire generation when crushable OxyContin was first prescribed, and I fear this crushable, pure hydrocodone pill will take us backwards with a new wave of addiction and tragic, untimely deaths," Rogers said in a press release. "While there isn't a silver bullet, abuse deterrent formulations offer common sense measures to curb the tide of overdose deaths in this country."