FDA Requests Removal of Opana ER from Market

Update: This story was originally published June 20. On July 6, Endo Pharmaceuticals announced that it would stop selling Opana ER in the United States. The decision came nearly a month after the Food and Drug Administration asked the drugmaker to withdraw the opioid medication because of its potential for misuse and abuse. The original story is below.

The FDA asked Irish drug company Endo Pharmaceuticals on June 8 to withdraw the painkiller Opana ER from the market. This marks the first time the agency has requested the removal of an opioid medication from sale because of public health concerns.

The request comes three months after an advisory panel created by the FDA decided that the risks of Opana as a drug of abuse outweigh its benefits as a painkiller.

“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,” Dr. Scott Gottlieb, FDA commissioner, said in a statement.

Opana, also known as oxymorphone hydrochloride, is a semi-synthetic opioid used to treat moderate to severe pain. It is generally prescribed when daily, around-the-clock opioid treatment is necessary for extended periods of time and when alternative treatment options are ineffective.

About twice as potent as OxyContin, Opana can cause life-threatening respiratory depression, hypotension and neonatal abstinence syndrome, an opioid withdrawal disorder that can occur in newborns. Even when used as prescribed, the drug can result in addiction.

The medication was approved for use in 2006. While Endo updated the drug’s formula with a hardened coating to prevent abuse by injecting or snorting in 2012, many drug users found ways to inject the drug. The FDA refused Endo’s request to add a label listing the abuse-deterrent properties of Opana ER.

After reviewing available data, the FDA concluded that Opana’s new formulation would not substantially reduce abuse of the drug.

Endo may not comply with the FDA’s request. In a statement, the drugmaker reaffirmed its commitment to improving pain management and minimizing misuse of its products. The company also stated that the FDA did not express concerns about Opana’s efficacy or safety when taken as recommended by a physician.

The drugmaker maintained its confidence in existing research suggesting that Opana has more benefits than risks when used as prescribed.

Opana ER Linked to HIV Outbreak in 2015

This is not the first time Opana has made headlines.

In 2015, an HIV outbreak began among Opana users in southeastern Indiana. The practices of injecting the drug and sharing syringes caused the virus to spread.

Thirty cases of HIV were reported in the area in February 2015. Two months later, the CDC reported the number had increased to 136 cases, and 85 percent of infected patients were also diagnosed with hepatitis C. By April 2016, the number of HIV cases in southeastern Indiana ballooned to 190.

In March 2015, former Indiana Gov. Mike Pence declared a public health emergency in Scott County, a rural community greatly affected by the outbreak. The next month, the Indiana State Department of Health told CNN that although the town had just one doctor who handled infectious diseases, he did not specialize in HIV. The state provided additional help to the area.

Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said in a statement that abuse of the current version of Opana by injection caused this outbreak. She said that the agency’s recent request to remove the medication from the market will help prevent future misuse and abuse of the drug.

Endo Pharmaceuticals’ Legal Troubles

Nassau County, New York, warned its citizens in 2011 of the consequences of Opana abuse after the county experienced an increase in prescribing and abuse of the medication. The next year, USA Today reported that hundreds of people in Nassau County were seeking rehab for Opana addiction each month.

In March 2016, Endo agreed to pay a $200,000 fine after New York Attorney General Eric Schneiderman accused the company of downplaying the consequences of using Opana. He also said that the drugmaker marketed the medication as crush-resistant despite evidence contradicting this claim.

In addition to the fine, Endo was ordered to:

Endo’s marketing practices were again scrutinized in May 2017, when Ohio Attorney General Mike DeWine sued the company and other drugmakers for violating numerous state laws, engaging in Medicaid fraud and contributing to the opioid epidemic.

In a press conference, DeWine claimed that pharmaceutical companies spent $168 million in 2014 to launch marketing campaigns downplaying the dangers of their medications. He also said that 2.3 million Ohioans, about one-fifth of the state population, were prescribed opioids in 2016.

“We understand what we’re taking on: five huge drug companies,” said DeWine. “I don’t want to look back 10 years from now and say we should have had the guts to file. … It’s something we have to do.”

Purdue Pharma, Johnson & Johnson, Teva Pharmaceuticals and Allergan were also named in the suit. Ohio is the second state, after Mississippi, to file an opioid-related lawsuit of this magnitude against Big Pharma.