The U.S. Food and Drug Administration published a formal request yesterday asking that drugmaker Endo Pharmaceuticals pull an opioid medication that it makes, Opana ER, from the market. This is the first time the FDA has ever “taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse,” according to the agency's press release.
The drug, which is manufactured for severe, “around-the clock” pain is already a reformulated version which was released in 2012 after the original was found to be easily crushed for injection and potential abuse. Despite reformulation, Opana ER is now one of several notoriously abused opioids currently fueling a rising epidemic. The drug was also at the center of a large outbreak of HIV among addicts in rural Indiana in 2015, when at least 181 people were infected.
The FDA does not on its own pull drugs from the market, but instead requests “voluntary” removal. Should the drug maker refuse to remove it on its own, the FDA would then “remove approval,” which would effectively ban the drug.
