A drug manufacturer has agreed to pull a prescription painkiller off the market after the Food and Drug Administration (FDA) asked it to do so in an effort to stem the country’s escalating opioid crisis, Medscape reports.
As previously reported, last month, the FDA ordered Endo Pharmaceuticals to pull its extended-release opioid Opana ER from U.S. pharmacies. The agency threatened to revoke the medication’s approval if the company did not comply.
Opana ER is marketed as a long-acting formulation of oxymorphone that was designed to discourage abuse. But post-marketing data revealed that some people using the drug illicitly had shifted from sniffing the crushed pills to injecting them after the product’s reformulation.
The FDA’s June request came in the midst of an accelerating opioid epidemic across the United States. The number of opioid overdose deaths has quadrupled over the past two decades, according to the Centers for Disease Control and Prevention. The CDC says more than half a million people have died from drug overdoses since 2000, and 91 Americans die every day from an opioid overdose.
Along with an increased risk of overdose, injection instead of nasal use of opioids adds the risk of transmitting HIV, hepatitis B and hepatitis C via shared syringes and other injection equipment. New cases of hepatitis C have recently hit a 15-year high, according to the CDC.
FDA officials said Opana use has been associated with recent outbreaks of HIV, hepatitis C and thrombotic microangiopathy, a serious blood disorder spread through shared needles. An FDA advisory committee voted in March that the risks associated with Opana ER outweigh the benefits.
Endo said in a statement that it “continues to believe in the safety, efficacy and favorable benefit-risk profile” of Opana ER when used as intended. Nevertheless, the company said that after consultation with the FDA it has decided to voluntarily remove Opana ER from the market.
The company said it would work with the FDA to coordinate the “orderly removal” of Opana ER from the market to minimize treatment disruption for patients taking the drug for pain relief.