Endo Pharma agrees to pull Opana ER from market

Endo Pharma agrees to pull Opana ER from market

Endo Pharmaceuticals has agreed to pull Opana ER from the U.S. market, several weeks after being asked to do so by the FDA. The abuse-deterrent extended-release formulation of the opioid painkiller oxymorphone hydrochloride has been tagged by an Agency safety committee as too easily abused. Opana ER was at the source of deadliest outbreak of HIV/AIDS and Hepatitis C in a decade, along with a high rate of overdose deaths, among addicts in Indiana and nearby states. In its defense, Endo stated that it still believes in “the safety, efficacy, and favorable benefit-risk profile” of the painkiller when used as intended. “Nevertheless,” the company stated, “after careful consideration and consultation with the FDA following the FDA's June 2017 withdrawal request, the company has decided to voluntarily remove Opana ER from the market.”

Requested in June

As we recently reported, the FDA asked Endo to remove Opana ER from the market in June, based on a review of “postmarketing data” which revealed that addicts were easily overcoming the abuse-deterrent formulation and injecting the drug. Needle-sharing – even among members of the same family – has been the source of the spread of HIV and Hep-C infections. And Opana ER abuse has also been found to be the source of ‘thrombotic microangiopathy’ among abusers. This rare but serious blood clotting disorder damages the tiny blood vessels in the body's vital organs, most commonly the kidney and brain, and can be fatal. A single Opana ER pill contains an average 12-hour dose of oxymorphone. The drug is 10 times as potent as morphine, and is intended only for serious pain control. However, when abusers crush, dissolve and inject it, that huge 12-hour dose of oxymorphone is suddenly an overdose risk for any but seasoned addicts. Of course, needle sharing by infected users raises the public health threat to the level of a disaster.

Not the first time

According to the FDA statement, “this is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse.” Well, that statement is not 100% accurate. Back in 1979, the agency asked Endo Pharmaceuticals to remove its oxymorphone painkiller pills, called Numorphan, from the market. That less-than-timely request followed a vicious epidemic of overdoses, ruined lives and deaths directly caused by diverted Numorphan pills, and which went on for 20 years – from 1959 to 1979 – before anyone did anything about it. Neither the FDA nor Endo Pharmaceuticals admitted publicly they had anything to do with the epidemic or why Numorphan pills were suddenly pulled from the market. Although the Numorphan pills were withdrawn, the Numorphan name remained on several injectable and rectal oxymorphone medications from Endo.

The new epidemic isn’t news either

As we reported two years ago, Opana ER was a favorite of opioid addicts centered around Austin, IN, and elsewhere for years. One has to ask why the FDA sat idle for at least two years while the epidemic spread, claiming over 120 victims in the tiny city of Austin, IN, pop. 4,200 – and beyond. Or why the agency was paralyzed for 20 years while Numorphan ravaged the opioid addiction underworld through the ‘60s and ‘70s. One also has to wonder why, in 2006, the FDA “reapproved” Endo’s Numorphan oxymorphone pills under a new trade name, Opana. And then in 2011, the agency approved the extended release Opana ER. Bottom line, this is not the first time the FDA has asked for a market removal “due to the public health consequences of abuse.” Today’s Opana ER is essentially the same product, albeit extended release, that the FDA had Endo remove from the market 38 years ago because of abuse. In its favor, Endo says it will coordinate the orderly removal of Opana ER from the market with the FDA, so that patients have enough time to seek alternative treatment options.

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