The current opioid epidemic sweeping the country has the US Food and Drug Administration nipping at the heels of drug manufacturers.
The FDA has mandated that Endo Pharmaceuticals remove Opana ER, a powerful painkiller, from the market, CNN reports. This is the first time the agency has asked a manufacturer to pull out an opioid drug due to “the public health consequences of abuse.”
Scott Gottlieb, FDA Commissioner, said, “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.” He added,
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.
Opana was the drug that many addicts in Indiana were taking during an HIV outbreak in 2015. The drug is two times more powerful than OxyContin, which is another abused opioid.
Opana ER, or oxymorphone hydrochloride, is prescribed for severe pain management. It is required daily, and has to be taken around the clock for a long period of time. The drug received FDA approval in 2006.
Andrew Kolodny, co-director of opioid policy research at the Heller School for Social Policy and Management at Brandeis University, said, “My comment is ‘wow.’ This is pretty exciting. This is big news.”
Kolodny added that while this is a “good sign” in the battle against opioid abuse, there are other drugs that likewise need to be pulled off pharmacy shelves.
Endo had previously tried to make Opana ER less accessible for addicts by making a hard coating for it. The drug is intended to be released over time, but drug abusers crush the pill to get a greater high in one go.
When Endo changed the formula in 2012, the more determined addicts began injecting it instead. In Indiana, shared needles due to this practice helped spread the HIV infection to over 142 people.
The FDA said this decision comes from a review of all post-market data, which shows that people have taken to injecting more than snorting the drug. This method also caused a hepatitis C outbreak, and a serious blood disorder.
For its part, Endo is reviewing the FDA request, and is assessing its next step “as we determine the appropriate path forward,” a statement from the company read.