Wednesday, April 02, 2014

Massachusetts bans FDA-approved Painkiller Zohydro

Zohydro ER is an opioid agonist, extended-release, oral formulation of hydrocodone bitartrate indicated for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate.

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, and because of the greater risks of overdose and death with extended-release opioid formulations, reserve Zohydro ER for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or immediate-release opioids) are ineffective, not tolerated, or would be otherwise inadequate to provide sufficient management of pain.
Zohydro ER is not indicated for use as an as-needed analgesic.
"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.
“Zohydro is basically pure synthetic heroin and comes in pills as large as 50 milligrams,” said Avi Israel, a North Buffalo resident whose son, Michael, committed suicide in 2011 after struggling with an addiction to prescription painkillers for the treatment of Crohn’s disease.
Unlike other pharmaceutical opiate pain medications, Zohydro, an extended time-release capsule, consists of hydrocodone without the familiar additives of aspirin or acetaminophen, making it stronger than other painkillers.