Tom Wilemon

twilemon@tennessean.com

A powerful new pain medication approved by the U.S. Food and Drug Administration that easily can be manipulated by abusers has officials in Tennessee and other states worried.

Called Zohydro, it’s an extended-release form of hydrocodone that comes in a capsule without safeguards to keep it from being crushed and injected.

“The Tennessee Department of Health believes sufficient varieties and types of prescription opioids already exist to meet the needs of patients in Tennessee, including those who may benefit from long-acting formulations with safety features designed to minimize risks to their health,” the agency said. “We are concerned about the use of Zohydro due to the absence of these safety features.”

An opinion piece this week in The New England Journal of Medicine also expressed concerns about the new medicine. Dr. Yngvild Olsen and Dr. Joshua M. Sharfstein wrote it is “time for the FDA to address the intertwining of chronic pain and addiction farther upstream in the drug-development cycle.” They noted the FDA’s advisory committee had voted 11-2 against approval.

Tennessee’s Robert E. Cooper Jr. was one of the attorneys general from 28 states and one U.S. territory who signed off on a letter to the FDA asking it to reconsider the decision. A FDA deputy commissioner responded in a letter saying the drugmaker was working to develop an abuse-deterrent form of Zohydro.

“Until then, after careful consideration, FDA determined that the benefits of Zohydro ER outweigh its risks, even though the product does not have abuse-deterrent properties,” Sally Howard, the deputy commissioner, wrote. “The available data demonstrate that Zohydro ER is safe and effective for the treatment of pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternative treatments are inadequate.”

Massachusetts Gov. Deval Patrick tried to ban Zohydro in his state, but a federal judge struck down the action at the request of the drug’s maker. Vermont Gov. Peter Shumlin issued emergency rules for doctors to follow when prescribing the drug.

Dr. Terry Alley, an addiction specialist with Cumberland Heights, said the oral medicine could be abused in two ways: snorting it or injecting it.

Reach Tom Wilemon at 615-726-5961 and on Twitter @TomWilemon.