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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…

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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Although the Numorphan pills were withdrawn, the Numorphan name remained on several injectable and rectal oxymorphone medications from Endo.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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There’s never been anything quite like this – a Big Pharma drugmaker formally agreeing with a big city to follow a “truth in advertising” program – essentially a code of conduct for marketing opioids that many officials hope will save lives, and become standard practice throughout the…

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The Food and Drug Administration (FDA) has approved Narcan nasal spray, the first FDA-approved intranasal naloxone hydrochloride spray. Naloxone is used to arrest the potentially fatal effects of an opioid overdose, particularly potentially fatal respiratory failure. Adapt Pharma Inc., licensed…

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FED UP! Coalition, a grass-roots coalition of individuals, organizations and doctors concerned about the overuse of prescription opioid painkillers, is calling for the U.S. Senate to release records obtained over three years ago from an official investigation into suspicious financial ties between…

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(Novus reports to professionals in the treatment industry to help support those that work to handle the epidemic of addiction in the US.) Since cracking down on "pill mills" in the state, and introducing the state's new prescription drug monitoring program (PDMP) a few years ago, Florida is…

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Novus is the best way to get your life back as painlessly as possible.

Call to speak to one of our experienced & caring detox advisors today!

When the prescription opioid painkiller Numorphan in pill form was taken off the market 36 years ago in 1979, most people working in addiction treatment breathed a sigh of relief. Throughout the 1960s and ‘70s, Numorphan (generic name oxymorphone) was seen to be responsible for countless…

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Part 1 | Part 2 | Part 3 | Part 4 | Part 5 | Part 6 SUBOXONE AND SUBUTEX Suboxone and Subutex are manufactured by Reckitt Benckiser Pharmaceuticals, Inc. These opioid drugs were approved by the Food and Drug Administration in 2002. Only doctors approved by the Substance Abuse and Mental Health…

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Novus is the best way to get your life back as painlessly as possible.

Call to speak to one of our experienced & caring detox advisors today!

Lots of court action underway as states seek $billions in damages from drug makers In the highly specialized world of medical treatment of substance abuse, we here at Novus are pretty much focused on just one thing — providing the very best medical drug and alcohol detox in the world to our…

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Prescribed by Doctors or Taken for FUN And the pain of coming off it can stop most people from trying... If you're having a problem with OxyContin dependence, you're not alone. OxyContin dependency and OxyContin addictions are an epidemic sweeping the country. OxyContin, like heroin,…

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