FDA Requests Popular Opioid Be Taken Off The Market

In an unprecedented move, the US Food and Drug Administration has made a request for Endo Pharmaceuticals to remove the powerful opioid painkiller, Opana ER, from the market. This is the first time they have ever made a formal request that an opioid be taken off the market stating that the risk now outweighs the benefits. “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. “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.”1 Opana, typically used to manage severe pain on a daily basis, was approved for use in 2006. It is an extremely powerful prescription painkiller – almost two times stronger than Oxycontin. Typically, they come in pill form but many people who are addicted to them end up crushing them up and snorting them. Even after Endo reformulated it to make it harder to crush, people began to inject it instead. Though this is the first time the FDA has made a formal request for any opioid to be removed from the market, it’s not the first time Endo has had any issues with the FDA. When they reformulated the pill to make it hard to crush, the FDA declared that there weren’t enough data to support that it would reduce the chances of the drug being abused. They declined a request for a label to include that the reformulation would deter any chances of abuse. Endo Pharmaceuticals is currently reviewing the FDA’s request and has released this statement: “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.”2