FDA Requests Opioid Painkiller Be Removed From The Market, Citing Abuse Risks, HIV Outbreak

The Food and Drug Administration has asked Endo Pharmaceuticals, the manufacturer of Opana ER, an extended-release semi-synthetic opioid painkiller, to remove the drug from the market, after the agency concluded that the drug’s potential for abuse outweighed its therapeutic value.

Endo had reformulated Opana ER (oxymorphone hydrochloride) to make it more difficult to abuse, but the FDA determined that this change ultimately resulted in a “significant shift in the route of abuse of Opana ER from nasal to injection.”

Oxymorphone hydrochloride is known for the potent high that results when it is ground, mixed with water, and injected. It has a short half-life, meaning the desired high is gone sooner than with other opioids. As a result, some who abuse Opana ER are injecting the drug more frequently.

The FDA was able to link the shift from Opana inhalation to injection with a serious outbreak of HIV and hepatitis C, as well as cases of thrombotic microangiopathy, a dangerous blood disorder.

“When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research in a statement. “This action will protect the public from further potential for misuse and abuse of this product.”

Opana was linked to the 2015 HIV outbreak in the rural Indiana community of Austin that resulted in dozens of confirmed HIV cases in a town of only around 4,000 people. The outbreak was so severe that then-Governor Mike Pence declared a public health emergency, creating a temporary exception to the state’s ban on needle exchange programs. Though Pence had openly opposed needle exchanges, he eventually signed a new law that allows for their use in similar emergencies.

When reached for comment by Consumerist about the FDA’s request, Endo would not say whether it will oblige the FDA and remove Opana ER. Instead, the company says it is “evaluating the full range of potential options as we determine the appropriate path forward.”

Endo contends that the FDA’s request for removal “does not indicate “uncertainty with the product’s safety or efficacy when taken as prescribed. Endo remains confident in the body of evidence established through clinical research demonstrating that Opana ER has a favorable risk-benefit profile when used as intended in appropriate patients.”

The FDA says that if Endo is not willing to voluntarily remove the product from the marketplace, they will take steps to formally require its removal.

“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,” said FDA commissioner Scott Gottlieb.