Due to public health consequences of abuse, the FDA announced that a powerful opioid painkiller must be removed from the market.
The Food and Drug Administration (FDA) announced yesterday that drugmaker Endo Pharmaceuticals must stop selling its powerful opioid medication, Opana ER. The agency requested that the opioid pain medication be removed from the market over concerns that “the benefits of the drug may no longer outweigh its risks.”
“We are facing an opioid epidemic – a public health crisis – and we must take all necessary steps to reduce the scope of opioid misuse and abuse,” said FDA Commissioner Dr. Scott Gottlieb, in a press announcement. “We will continue to take regulatory steps when we see situations where an opioid product’s risks outweigh its benefits, not only for its intended patient population but also in regard to its potential for misuse and abuse.”
Opana ER, or oxymorphone hydrochloride, is an extended-release opioid prescribed for around-the-clock moderate-to-severe pain management. The FDA approved it for use in 2006. An increasing number of people, the FDA claims, are abusing the prescription pills by crushing, dissolving, and injecting them.
“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”
Because opioids depress central nervous system functioning and corresponding critical processes like respiratory rate, a person abusing them faces the risk of a fatal overdose. According to the Centers for Disease Control and Prevention, every day more than 91 Americans die from an opioid overdose, and about 1,000 are treated in emergency rooms for not using prescribed opioids as directed.
Dr. Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University told CNN that the FDA’s move is a “good sign” for the effort to address the nation’s opioid epidemic.
“My comment is ‘wow,’” said Kolodny. “This is pretty exciting. This is big news.”
“Opana is not the only one that needs to come off the market,” he added.
This is the first time the FDA has taken steps to remove an opioid from the market because of “public health consequences of abuse.” The move renews the argument that cannabis and its cannabinoids could prove to be a better option for managing chronic pain. Cannabis has shown to be an effective, non-addictive pain reliever and, according to the DEA, has never caused a fatal overdose. Having legal access to medical marijuana has shown to significantly reduce opioid pain medication intake and opioid-related hospitalizations. Professors, pain doctors, advisory boards, and medical experts have argued that cannabis could address the nation’s opioid epidemic.
A poll conducted earlier this year found that two-thirds of Americans believe cannabis to be a safer treatment for managing pain than prescribed opioids, and findings in a recent study show that more people are using cannabis as a substitute for prescription drugs. Twenty-nine U.S. states have legalized medical marijuana, and all nearly all have approved cannabis for pain management.
Endo Pharmaceuticals responded to the FDA’s request, saying that it is evaluating all of its options. If the company doesn’t pull Opana ER from the market, the FDA has said it will take the necessary steps to formally require the drug’s removal by withdrawing approval.