For the first time ever, the U.S. Food and Drug Administration has requested that a drug company take an opioid off the market because of the risk of addiction.
The FDA asked Endo Pharmaceuticals to stop selling Opana ER, despite the fact that the company had reformulated the drug in the past to try to reduce the risk of abuse.
According to the FDA, the reformulation didn’t solve the problem. The agency says abuse of the drug by injection is associated not only with addiction but also with an increased risk of HIV, hepatitis C, and a serious blood disorder.
Overall, the FDA says, the risks of the product outweigh 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,” said FDA Commissioner Scott Gottlieb. “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.”