Opana ER, a potent extended-release opioid, was approved by the FDA for pain management in 2006. But the agency says Endo’s attempts to reformulate the pills to make them harder to crush, dissolve and inject have not been successful.
The Food and Drug Administration requested Thursday that the drugmaker Endo Pharmaceuticals stop selling Opana ER — its extended-release version of Opana.
The FDA says the move marks the first time the agency has taken steps to remove an opioid from the market because of “public health consequences of abuse.”
An increasing number of people, the FDA says, are abusing the powerful prescription pills by crushing, dissolving and injecting them. The sharing of needles by these drug users has fueled an outbreak of associated infectious diseases — HIV, hepatitis C and another serious blood disorder.
“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,” says Dr. Scott Gottlieb, the FDA’s commissioner, in announcing the move.
“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,” Gottlieb says.
In a written statement, Endo says the company is “reviewing the request and is evaluating the full range of potential options as we determine the appropriate path forward.” The company defended its drug, a version of the medicine oxymorphone hydrochloride, citing the opioid’s effectiveness in alleviating pain and Endo’s efforts to prevent abuse.
“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,” according to the firm’s statement.
The FDA says if the company fails to voluntarily withdraw the drug the agency will force Opana ER’s removal from pharmacy shelves by revoking its market approval.
“In the interim, the FDA is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product,” the FDA says.
Opana ER was approved by the FDA for pain management in 2006 as an extended-release opioid. Each pill is designed by the manufacturer to be swallowed and to slowly release the medicine into the bloodstream over a number of hours. But if crushed and snorted or injected, the opioid can deliver a potent high in a single wallop.
As public health authorities and the FDA became increasingly concerned about the nation’s epidemic of opioid abuse and overdoses, the company reformulated the drug in 2012, by adding a coating that was intended to make it harder to snort or inject the medicine.
But that strategy appears to have backfired, according to the FDA’s review of postmarketing data. Injections of the drug by people with an addiction disorder have continued to trigger outbreaks of HIV, which causes the acquired immune deficiency disorder (AIDS), and hepatitis C, potentially fatal liver infection, as well some cases of the serious blood disorder known as thrombotic microangiopathy.
“When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” says Dr. Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.”
An FDA advisory committee voted in March that Opana ER’s benefits no longer outweighed its risks.Share