Healthcare Business News

Zohydro's FDA approval could fuel overdoses, critics warn

By Steven Ross Johnson
Posted: February 26, 2014 - 12:01 am ET

A collective of physicians and groups fighting substance abuse are appealing to the head of the Food and Drug Administration to reconsider the agency's approval of Zohydro, a prescription painkiller many fear will only contribute to the current epidemic of prescription drug abuse and overdoses.

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In a letter sent to FDA Commissioner Dr. Margaret Hamburg on Wednesday, the FED UP! Coalition requested that she reverse approval of the painkiller Zohydro ER, the first prescription opioid that will contain pure hydrocodone without combining it with a weaker substance such as acetaminophen.

In making its decision last October, the FDA went against the recommendations of the advisory panel it had commissioned to review the drug, which in 2012 voted 11-2 against its approval.

Critics of the FDA's decision contend that the new opioid medication, which is estimated to be 10 times stronger than other forms of hydrocodone, such as Vicodin, will lead to a new rash of drug overdoses and abuse because of its strength and highly addictive qualities. Critics are also concerned because Zohydro currently does not have tamper-resistant protections contained in other opioid pills to prevent them from being crushed and snorted.

“On behalf of consumer safety organizations, health care agencies, addiction treatment providers, community-based drug and alcohol prevention programs, professional organizations, and other groups on the front-line of our nation's opioid addiction epidemic, we ask you to put the public's health ahead of industry interests,” the petition stated. “In the midst of a severe drug epidemic fueled by overprescribing of opioids, the very last thing the country needs is a new, dangerous, high-dose opioid.”

Follow Steven Ross Johnson on Twitter: @MHSjohnson

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