FDA Could Act to Pull More Opioid Pain Pills From the U.S. Market

  • On Thursday, agency said Endo should stop sale of pill Opana
  • Drug agency’s action comes amid epidemic of addiction, deaths

FDA Makes Opioid Abuse a Top Priority

The Food and Drug Administration is examining the abuse potential of several more opioid pain pills amid an ongoing review of health risks from the drugs, which have been tied to thousands of overdose deaths a year.

On Thursday, the FDA asked Endo International Plc to stop sales of its powerful opioid painkiller Opana ER, the first time the agency has taken such a step. The request was made after the drug was tied to outbreaks of viral infections including HIV, as addicts would inject the drug and spread disease by sharing needles.

Several other related opioids are on the agency’s radar, including two generic pills -- oxymorphone extended release and oxymorphone immediate release. The drugs were discussed at a March advisory meeting held by the agency, and the agency “is currently assessing the latest available data on abuse patterns” for the two drugs, said FDA spokeswoman Sarah Peddicord. Oxymorphone is the active ingredient in Opana.

Representatives for Mallinckrodt Plc, Hikma Pharmaceuticals Plc and Impax Laboratories Inc., which make the generic drugs, according to the companies’ websites, didn’t immediately respond to requests for comment.

FDA Commissioner Scott Gottlieb said Thursday that the FDA would look at not just opioid drugs’ risks and benefits in legitimate patients, but also at the drugs’ potential for illicit use. The agency believes it has the legal authority to do so, 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.

Opioid Epidemic

Thousands of Americans die each year from opioid overdoses, as do many more who switch from the pills to heroin. The FDA doesn’t typically order drugs off the market, but asks their makers to pull them -- which they usually do.

One possibility the FDA has raised in the past is pulling some versions of a drug from the market once abuse-deterrent versions, or improvements, become available.

An example in that category is Zohydro, a powerful painkiller that was approved by the agency in 2013 without an abuse-deterrent mechanism. It was approved despite an 11-2 vote by an outside advisory group to the FDA recommending against making the drug available. Despite the approval in 2014 of an abuse-deterrent form of a similar drug by Purdue Pharma LP, the agency hasn’t acted to pull Zohydro.

“At this time, the FDA cannot speculate as to what action it may take in regard to other specific opioid products,” said the FDA’s Peddicord. A spokesman for Pernix Therapeutics, which makes Zohydro, didn’t immediately respond to an inquiry on whether the FDA was reviewing the drug.


While Endo’s drug Opana ER 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.

Endo’s shares plunged as much as 17 percent to $11.50 on Friday, the biggest intraday decline in seven months, and traded at $11.93 as of 12:43 p.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.

— With assistance by Robert Langreth

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