Tox Tuesday: FDA asks drug maker to pull powerful opioid painkiller

June 13, 2017

For the first time ever, the U.S. Food and Drug Administration (FDA) has asked a pharmaceutical company to take one of its products off the market.

Endo Pharmaceuticals produces Opana ER, a highly potent opioid painkiller intended for patients who require “daily, around-the-clock, long-term opioid treatment…for which alternative treatment options are inadequate.”

The drug, like other prescription painkillers, is often abused, thanks to the extremely addictive nature of opioids. The FDA makes its request in the midst of an epidemic of opioid addiction in the U.S., a problem increasingly present in other parts of the world as well.

“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. “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 ER, or oxymorphone hydrochloride, is twice as powerful as another opioid painkiller, OxyContin, according to CNN.

In an effort to make it harder to abuse, Endo has reformulated its product by giving each pill a coating that makes it harder to crush. Abusers sometimes crush drugs, then snort or inject the powder to get high quickly, instead of swallowing the pill and letting it release slowly into the body.

According to the FDA, the injection method of taking the drug was leading not just to overdoses and addictions, but also to an increase in HIV, hepatitis C and other serious blood-borne health problems, through needle sharing.

An independent panel of drug experts put together by the FDA voted 18-8 that the risks outweighed the benefits of the drug.

“The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak,” Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement. “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market. This action will protect the public from further potential for misuse and abuse of this product.”

The FDA has said that if Endo does not voluntarily remove Opana ER from the market, it will revoke its approval of the drug, which would formally require its removal.

In a statement, Endo acknowledged the ongoing opioid crisis in the U.S., and said that it was evaluating its options regarding the FDA request.

“As a pharmaceutical company with a demonstrated commitment to the improvement of pain management, Endo feels a strong sense of responsibility to improve the care of pain for patients while at the same time taking comprehensive steps to minimize the potential misuse of its products,” the company said.

“Despite the FDA’s request to withdraw Opana ER from the market, this request 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.”

Nearly half of all U.S. opioid overdose deaths in 2015 — there were over 33,000 of them, according to the U.S. Centers for Disease Control and Prevention — were attributed to prescription drugs.

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Category: Toxicology