FDA asks painkiller-maker to halt sales

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 pain relief, it’s become a favorite of addicts. After Endo reformulated the drug to try to 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 postmarket consideration,” Gottlieb said in a phone interview.

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.