Massachusetts bans FDA-approved painkiller

Massachusetts Gov. Deval Patrick (D) is banning the controversial prescription drug Zohydro from his commonwealth.

The Food and Drug Administration has drawn widespread criticism from lawmakers for approving what experts say is a highly addictive and easily abused painkiller.

{mosads}”Zohydro is a dangerously addictive pharmaceutical painkiller, approved by the FDA recently over the objection of their scientific advisory council, and is not available in an abuse-deterrent form,” Patrick said in a recent speech announcing the ban.

“Until it is available in an abuse-deterrent form, or better, until the secretary of [Health and Human Services] or the Congress has acted on the requests to overturn the FDA, Zohydro will not be available in Massachusetts,” he said.

The news from Massachusetts comes after a long line of criticism has been directed at the FDA over its approval of Zohydro.
 
But Zogenix, the company that makes Zohydro, shot back at the governor, calling it an “unprecedented action” that “only serves to unfairly restrict patient access” to the medication.

“Ultimately, the ban on the prescription medication will add to patient suffering in the state,” the company said in a statement to Reuters.

Zohydro is the first FDA-approved drug that uses pure hydrocodone to treat chronic pain. The FDA approved the painkiller last October, despite warnings from the agency’s own experts that it poses a danger to society.

Other combination drugs mix hydrocodone with weaker, nonaddictive painkillers like aspirin to balance out the effects. But Zohydro contains up to 10 times as much hydrocodone as some combination drugs like Vicodin, experts say.

Critics say Zohydro could increase prescription drug overdose rates, because it is addictive.

A number of lawmakers have written letters to FDA Commissioner Margaret Hamburg, requesting that she reverse the agency’s decision. Some also asked Health and Human Services Secretary Kathleen Sebelius, who oversees the FDA, to go over Hamburg’s head.

Still other lawmakers are working on legislation that would force the FDA to withdraw approval of Zohydro.