On Thursday, the FDA said it wants the oxymorphone product Opana ER removed from the market , capping years of controversy over the opioid painkiller. Here we republish that investigation to provide context for the recent FDA action. In , in the midst of a growing opioid epidemic, the FDA approved the new narcotic painkiller Opana.
Under the name Numorphan, it had been abused in the s and s until it was removed from the market. When injected, the drug is 10 times as potent as morphine.
Known generically as oxymorphone, the FDA approved the new version of the drug -- made by Endo Pharmaceuticals -- in as both an immediate-release and extended-release pill. Then in December , the agency approved a new abuse-deterrent version -- but users have been able to foil the anti-injection mechanism and have been shooting up Opana.
In addition to overdose risk, abuse of Opana by injection has been tied to a recent outbreak of HIV in rural Indiana as well as a surge in hepatitis C infections in several Appalachian states. It also has been associated with a blood-clotting disorder and permanent organ damage -- a problem that didn't occur with injection abuse of generics and the earlier version of the drug. As Numorphan, the drug's popularity among addicts was due to its quick and sustained effect, according to the report "Drugs and Addict Lifestyle" by the National Institute on Drug Abuse.
The report said the drug -- which carried a street name of "blues" -- was used primarily by white males and highlighted Philadelphia area addicts who were interviewed about their Numorphan abuse in Many of the addicts said they preferred the drug over heroin. Originally approved in , FDA records indicate the pill form of Numorphan was taken off the market in for what is described as " commercial reasons. In an email, FDA spokesman Eric Pahon said opioids, including Opana, are important medications for the treatment of pain, when used properly.
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It furthers the University's objective of excellence in research, scholarship, and education by publishing worldwide. Sign In or Create an Account. Sign In. Advanced Search. Search Menu. Article Navigation. Close mobile search navigation Article Navigation. Volume Oxymorphone in Special Populations.
Clinical Pharmacology of Oxymorphone. Smith, MD Howard S. Smith, MD. Oxford Academic. PDF Views. Cite Cite Howard S. Taking either medication not as prescribed can lead to overdose or death.
Your doctor may monitor you for signs of addiction during your treatment with Opana or Roxicodone. Ask your doctor about the safest way to take these medications. At the same time, you should also never stop taking Opana or Roxicodone without talking to your doctor.
Stopping either drug suddenly can cause withdrawal symptoms, such as:. When you need to stop taking Opana or Roxicodone, your doctor will slowly lower your dosage over time to decrease your risk of withdrawal. Opana and Roxicodone are both available as generic drugs.
The generic version of Opana is called oxymorphone. Your health insurance plan will likely cover the generic version of Roxicodone. However, they may require you to try a less-powerful drug first. For brand name versions, your insurance may require a prior authorization. Opana and Roxicodone work in the same way, so they cause similar side effects. The more common side effects of both drugs include:. Opana and Roxicodone share similar drug interactions. Always tell your doctor about all prescription and over-the-counter drugs, supplements, and herbs you take before you start treatment with a new medication.
If you take either Opana or Roxicodone with certain other drugs, you may have increased side effects because certain side effects are similar between the drugs. These side effects can include breathing problems, low blood pressure, extreme tiredness, or coma. These interacting medications include:. Other drugs can also interact with these two drugs.
For a more detailed list of these interactions, please see the interactions for Opana and interactions for Roxicodone. Opana and Roxicodone are both opioids. They work similarly, so their effects on the body are also alike. If you have certain medical issues, your doctor may need to change your dosage or schedule. In some cases, it may not be safe for you to take Opana or Roxicodone.
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