For the first time, the U.S. Food and Drug Administration has asked a drug manufacturer to remove an opioid painkiller from the market. In June, the FDA directed Endo Pharmaceuticals to recall its potent opioid painkiller Opana ER.
“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,” FDA Commissioner Dr. Scott Gottlieb said in a statement.
“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.”
The drug is about twice as powerful as OxyContin, with a similar potential for addiction, according to Drugs.com.
Opana ER, oxymorphone hydrochloride, is used to manage pain severe enough to require daily, around-the-clock, long-term opioid treatment for which alternatives aren’t strong enough, according to the manufacturer’s website. The FDA approved it for this use in 2006.
“My comment is ‘wow,'” said Dr. Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University. “This is pretty exciting. This is big news,” Kolodny told CNN.
Though it is a “good sign” for the fight against opioid abuse, he said, “Opana is not the only one that needs to come off the market.”
Opana ER made news in 2015, because it was used by many addicts caught in an HIV outbreak in Indiana. A year later, the number of HIV cases had reached 190, according to the Indianapolis Star.
Endo had tried to discourage addicts from using Opana ER by making it with a waxy coating that made it difficult to crush into powder. The medication is designed to release over time, but addicts had been crushing it to get a sudden, pronounced high.
The drug’s warning label specifically cautions users not to break the tablets down before ingesting orally, because it “leads to the rapid release and absorption of a potentially fatal dose of oxymorphone.”
When the drugmaker changed the formula in 2012, some addicts starting injecting it intravenously, instead.
The FDA said it made its latest decision based on a review of all post-market data, which suggested that when the company reformulated the medication, people were injecting it more than they were snorting it. This method of delivery also caused a serious outbreak of hepatitis C and a serious blood disorder, according to the agency.
The announcement followed a vote in March by an FDA-assembled, independent panel of experts, who voted 18-8 that the benefits of reformulation no longer outweighed the risks.
In a statement, Endo said it is reviewing the FDA’s request and evaluating all its options “as we determine the appropriate path forward.”
“While the benefits of opioids in treating and managing pain are widely recognized, the misuse and abuse of these products have increased greatly in the U.S. As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products.
“Despite the FDA’s request to withdraw Opana ER from the market, this request does not indicate uncertainty with the product’s safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.”
Doctors say the effects of Opana are closer to those of morphine than of OxyContin. While OxyContin is more of a stimulant, Opana can cause a user to fall asleep. Like morphine, Opana’s greatest danger to abusers is the possibility of “respiratory depression,” or reduced lung functioning.
An injectible form of the drug – known under the generic name of oxymorphone hydrochloride – has been available since 1959, but was available only as an intravenous drip to hospitals. The oral form was originally approved by the Food and Drug Administration in 5, 10, 20 and 40 milligram extended release tablets, and immediate release tablets in 5 and 10 milligram doses. The FDA later approved three additional doses.