BAY VILLAGE -- Dozens of public health groups, 29 state attorneys general and some members of the Greater Cleveland- Cuyahoga Community-Wide Heroin/Opiate Task Force are urging the Food and Drug Administration to revoke approval of a powerful new prescription painkiller that hits the market this month.
It's called Zohydro.
"It's five to ten times stronger than any hydrocodone on the market now," says Bob Walling, a special agent for the Westshore Enforcement Bureau Drug Task Force. He specializes in pharmaceutical abuse cases.
"This stuff is so potent one pill can kill a child, two or three pills can cause an overdose in an adult," says Bob Garrity, a criminal defense attorney, drug counselor, former pharmacist and recovering opiate addict who has been clean for 13 years.
Zogenix, the company that makes Zohydro, cautions medical professionals on its website:
"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."
Because of the opioid epidemic, similar drugs like Oxycontin now come with abuse deterrents. Zogenix says an abuse deterrent version is still three years away.
Walling fears release of the drug will add to his caseload.
"You can pull the capsule apart and snort it and mix it with saline and inject it very easily, it's going to be a very easy drug to abuse," Walling says.
Garrity thinks a safer version is possible sooner.
"If the FDA told them right now 'We're not going to approve it until you get the abuse deterrent,' I guarantee they'd have it out in six months," Garrity says.
From his perspective as a former addict, he knows this drug will be hot on the street. He fears crime is going to increase.
"It's gonna be a big seller for all the dealers. They're gonna have mules going to the pharmacies to get it, pharmacy robberies will increase, and addicts are going to think 'Yeah, maybe this is the right drug that's going to be the one for me,' " Garrity says.
Cuyahoga County Medical Examiner Dr. Thomas Gilson released the following statement:
"In light of the ongoing epidemic of prescription narcotic fatalities, as well as the dramatic rise in heroin deaths, the introduction of any potent painkiller like Zohydro is a source of concern. The unintended consequences of releasing this drug in a formulation that raises concerns about potential abuse could be devastating. It would seem prudent to at least delay the release until a more abuse-resistant version could be developed."
Also, Aaron E. Haslam, executive director of the state medical board said the following:
"Patient safety is the State Medical Board of Ohio's number one priority. Zohyrdo's introduction to the market offers another pain management treatment tool for physicians. Yet, there is also risk for the potential misuse and or abuse of this class of narcotics. The State Medical Board of Ohio recommends all prescribers use smart clinical judgment with any controlled substance. Zohyrdo should be prescribed with the same care and caution."
Zogenix says there's a needed market for Zohydro because it does not contain acetaminophen and is easier on the liver. Critics say there are other alternatives that also don't contain acetaminophen.