The US Food and Drug Administration recently approved a new pain killer with 5 to 10 times more heroin-like narcotic than existing hydrocodone products like Vicodin, despite professed attempts to crack down on the US’s prescription painkiller epidemic. The drug, Zohydro ER, is an opioid analgesic with a high risk for abuse.
The FDA approved the highly potent painkiller against the advice of its own advisory committee, MedPageToday reports. Last year, the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee voted 11 to 2 against recommending approval of Zohydro.
Zohydro is the first single-entity hydrocodone analgesic to be approved by the FDA, or the first that is not diluted with non-opioid analgesics like acetaminophen and ibuprofen. The potent narcotic in Zohydro is designed to be slow-releasing; however, abusers will be able to crush, chew, or mix the drug with alcohol to feel the full effects instantaneously.
In 2010, the manufacturer of Oxycontin, one of the most abused painkillers in the US, reformulated its recipe to make the drug abuse-resistant. The FDA could have chosen to require the drug to be formulated with abuse-prevention technology but chose not to enforce such a requirement, despite an internal memo warning that the drug will be abused more than other hydrocodone painkillers.
The Centers for Disease Control and Prevention has said that fatal overdoses resulting from the use of painkillers have reached epidemic levels. And last month, the first-ever global study of illicit drug use found that, in high-income countries like the US, illicit opioid use is the most hazardous type of illicit drug use in terms of mortality, compared with other illicit drugs such as marijuana and cocaine.
In 2011, a testimony to the Senate Judiciary Committee from the American Society of Interventional Pain Physicians stated that Americans, “constituting only 4.6% of the world’s population, have been consuming 80% of the global opioid supply, and 99% of the global hydrocodone supply.”
At the FDA’s Anesthetic and Analgesic Drug Products Advisory Committee meeting last December, Dr. Judith Kramer, of the Duke Translational Medicine Institute, stated that she voted against approving Zohydro because “This drug will almost certainly cause dependence in the people that are intended to take it.”
“It’s striking to me… that this drug is, in a way, held to a lower standard because of all the other drugs that we’ve accepted this kind of profile on and have the history that we have with their approval,” she noted. “The non-deterrent formulation… is particularly worrisome because of the very high dose contained in an individual tablet, and the potential of abuse.”
In October, Janet Woodcock, Director of the FDA’s Center for Drug Evaluation and Research released a statement announcing plans to reclassify hydrocodone products from Schedule III to the more restrictive Schedule II, which would increase controls on products like Vicodin. Yet, the FDA’s approval of Zohydro may leave some questioning the FDA’s commitment to addressing the US’s prescription pain pill addiction epidemic.
“The FDA could have chosen to require the drug to be formulated with abuse-prevention technology but chose not to enforce such a requirement,” said Ned McWilliams a shareholder with the Levin, Papantonio law firm who practices in the areas of bad drug and defective medical device litigation. “The FDA made this decision despite an internal memo warning that the drug will be abused more than other hydrocodone painkillers.”