HAZARD-National concern has been raised about the U.S. Food and Drug Administration’s (FDA) recent approval of a new pain medication. Reports on CNN, USA Today, and other national news sources tout the potential dangers of this new high-dosage pain drug.
The new pain medication, Zohydro ER (Extended Release), is purported to be five to 10 times more potent than traditional hydrocodone products, and is the first ever hydrocodone-only opioid narcotic, however has no abuse-deterrent properties.
Kentucky Attorney General Jack Conway, along with attorney generals from 28 other states, signed a letter in December of last year urging the commissioner of the FDA to reconsider the approval of this drug.
“State Attorneys General do not want a repeat of the recent past when potent prescription painkilling drugs entered the market without abuse-deterrent qualities and without clear guidance on how they were to be prescribed,” the letter read.
Dr. John Scanlon, an addiction medicine specialist from Virginia Beach, Va., expressed his concerns about Zohydro ER.
“The Zohydro, as far as an addiction specialist goes, I would say that it would be dangerous from the standpoint of abuse potential,” Scanlon, who has practiced in Eastern Kentucky for many years, said.
Scanlon went on to define the difference between this particular medication and other types of pain medication available.
“That’s the difference between Loracet, Loracet Plus, and so forth and Zohydro. Zohydro is hydrocodone without Tylenol (acetaminophen) and the Tylenol helps prevent abuse,” he said.
Kenny Watts, clinic manager at Kentucky Pain Management in Hazard, said his clinic does not use the more popular drugs for pain management.
“We have not even considered the hydrocodone, the straight hydrocodone,” Watts said.
Helen F. Bruntly, the Perry County UNITE Drug Coalition Chair, said the main problem with this new medication is that there are no abuse deterrents.
“I am very concerned about the release of Zohydro due to its potency, addictive properties, and the fact that it does not have an abuse-deterrent formulation. I do not understand why the FDA approved this drug when the FDA’s own advisor panel of pain specialists voted 11-2 against it,” she said.
Zogenix, the makers of Zohydro, are reported to be working on an abuse-deterrent version of the drug that should be available in three years.
“The indication for Zohydro also disturbs me. It is defined in a way that will result in widespread availability and abuse of the drug,” Bruntly said.
Zogenix representatives cited examples of patients who might benefit from Zohydro such as someone with chronic back pain, metastatic breast cancer or a patient with multiple orthopedic fractures, however this patient group may expand much like other opioid-containing drugs have done to include patients with other chronic conditions.
Bruntly said the ease with which the Zohydro pills can be crushed and subsequently abused is terrifying for a community already ravaged by prescription drug abuse.
“It’s going to be deadly,” she said.
Gwendolyn Holliday can be reached at 606-436-5771, or on Twitter @HazardHerald