FDA moves to pull Endo’s opioid pain medication off the market
Citing public safety concerns, the U.S. Food and Drug Administration late last week took the rare step of aiming to remove an opioid pain medication from the market.
The agency requested that Endo Pharmaceuticals pull Opana ER, say- ing that risks associated with the medication outweigh the benefits.
It’s one of the first times that the FDA has tried to get an opioid pain medication off the market because of the public health consequences of abuse.
“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.”
Opana ER was reformulated in 2012 to make it harder to crush, ideally reducing abuse through snorting the painkiller. Instead many users dissolved and injected the drug, which has led to outbreaks of HIV and hepatitis C, according to the FDA.
The agency said it would take formal action to remove the product from market if Endo Pharmaceuticals denies the FDA’s request. In the meantime, the FDA is making healthcare professionals aware of risks associated with the painkiller. The agency will continue to review the risks and benefits of similar drugs.