The maker of opioid painkiller Opana ER is pulling the drug off the market at the request of federal regulators because it’s being abused.
The Associated Press reports Endo International PLC says it will voluntarily stop selling the pills—approved for use in patients with severe, constant pain—after consulting with the U.S. Food and Drug Administration.
It’s the first opioid drug that the FDA has sought to remove from the market due to abuse.
The drugmaker in a statement says the extended-release opioid is safe and effective when used as intended, and that Endo still believes Opana ER’s benefits outweigh its risks.
But last month, the FDA concluded the drug is too risky. The agency says it had seen a “significant shift” from people crushing and snorting the pill to get high to injecting it instead. Besides contributing to overdoses, abuse of Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern Indiana linked to sharing needles, according to the FDA.
Opana ER got U.S. approval in 2006. In 2012, Endo changed the drug’s formulation to try to make it harder to abuse. The FDA approved sales of the new version but refused to let Endo market it as abuse deterrent.
Read the full story and check out a recent Business Report cover story about how Louisiana’s opioid epidemic is impacting workforces nationally and locally.
