For the first time ever, the U.S. Food and Drug Administration is asking a pharmaceutical company to remove an opioid from the market due to the dangers of abuse. The drug is linked to Indiana’s HIV outbreak.
The FDA wants Endo Pharmaceuticals to voluntarily remove the reformulated Opana ER from the market. The company reformulated the opioid in 2012 to make it harder for people to crush and snort or inject, but people found another way to abuse Opana. Heating the pills melts the coating, allowing people to inject the drug. It was popular in Scott County, where the sharing of dirty needles sparked an HIV outbreak.
The FDA says the potential risks of abuse associated with Opana now 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,” FDA Commissioner 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 FDA’s request comes after the agency reviewed all data available about the use of Opana ER, which revealed significant abuse after the drug’s reformulation. In addition to the HIV outbreak, the FDA says abuse of the drug has been linked to cases of a serious blood disorder called thrombotic microangiopathy.
If the company doesn’t voluntarily remove Opana ER from the market, the FDA will begin the process to formally require its removal.
This story originally appeared on WFIU News.
