Amid an outbreak of dangerous infections by pain drug abusers, the U.S. Food and Drug Administration has asked Endo International Plc to stop sales of its powerful opioid painkiller Opana ER, the first time the agency has taken such a step.

While the drug was approved by the FDA for legitimate pain relief, it’s become a favorite of addicts. After Endo reformulated the drug to try and reduce its potential for abuse, many drug users went from crushing and snorting the pill to injecting it. That led to “a serious outbreak of HIV and hepatitis C,” the FDA said in a statement.

The move marks a shift in FDA policy, pushed by Commissioner Scott Gottlieb, to consider how opioids are used not just by appropriate patients but also by drug abusers. Thousands of Americans die each year from opioid overdoses, as do many more who switch from the pills to heroin.

The agency believes it has the legal authority to look beyond patients to whom the drug is prescribed and to include abusers in the risk-benefit calculation it considers when reviewing a drug, Gottlieb said.

“We’re going to be focusing policy attention on looking at risk-benefit not only in the labeled indication but also in the setting of the abuse of narcotics both in the pre- and post-market consideration,” Gottlieb said in a phone interview.

Gottlieb declined to say if there were other opioids that the agency was reviewing for similar risks. The FDA doesn’t typically order drugs off the market, but asks their makers to pull them -- which they usually do.

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Endo’s shares plunged as much as 13 percent to $12.04 on Friday, the biggest intraday decline in seven months, and traded at $12.15 as of 9:51 a.m. New York time.

The drugmaker said it is reviewing the request and “evaluating the full range of potential options as we determine the appropriate path forward.”

“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 company said in a statement. Sales of the drug totaled $158.9 million last year, about 4 percent of the company’s revenue.

In April, as he was being vetted for the commissioner spot, Gottlieb said that the opioid crisis would be the agency’s top priority. Last month, he set up a steering committee at the FDA to explore policies to reduce opioid use and reconsider whether the agency was doing enough to take into account the risk of abuse when evaluating opioids. The committee had its second meeting Thursday, unrelated to Opana ER, he said.

“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,” Gottlieb said in the statement announcing the request to pull the drug.

HIV outbreak

An HIV outbreak took place in Indiana in 2015, linked to the use of dirty needles by pain-pill abusers who injected the drugs.

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

The FDA has been reviewing the drug’s risks for several months. In March, an FDA advisory panel voted 18-8 that the benefits of Opana ER no longer outweighed its risks, because of the potential for abuse and misuse.

“For those on the street it is interchangeable with heroin,” one panel member, University of California, San Francisco, professor Daniel Ciccarone said during the March hearing.

The FDA says it has approved 10 opioid medications as abuse-deterrent, including Pfizer Inc.’s Troxyca and Purdue Pharma LP’s OxyContin.

Instant Insights /

FDA, in milestone for opioid crisis, asks Endo to pull pill

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