opana er off market

At FDA Urging, Drug Maker Pulls Opana ER Off Market

At the request of the U.S. Food and Drug Administration (FDA), Endo Pharmaceuticals has removed from the market its long-acting opioid pain medication, Opana ER (oxymorphone hydrochloride extended release), which some patients with arthritis take to manage chronic pain.

The FDA says this is the first time it has asked for an opioid medication to be pulled “due to the public health consequences of abuse.” The immediate-release version of the drug, Opana, is not affected by this action.

The FDA asked the company in early June to voluntarily remove Opana ER from the market – and threatened to withdraw its approval if the company didn’t comply – after an FDA advisory committee concluded in March that the benefits of the drug no longer outweighed its risks. The committee, made up of independent experts, voted 18 to 8 in favor of the decision.

Heather Zoumas Lubeski, a spokesperson for Endo Pharmaceuticals, told Arthritis Today the company complied with the FDA request, believing it to be “the most constructive path forward.” But she also stressed that her company continues to believe its medication is safe and effective when used as intended.

FDA Commissioner Scott Gottlieb, MD, said in a press release, “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.”

The U.S. Centers for Disease Control and Prevention (CDC) says more than 33,000 people died in 2015 from opioid overdoses – more than any other year on record – and nearly half of those deaths involved prescription opioids. In new data, published in the July 7 issue of the Morbidity and Mortality Weekly Report (MMWR), the CDC reported that prescriptions for opioid peaked in 2010 and have declined yearly through 2015, although the agency says prescribing rates are still too high.

In an effort to rein in opioid use the FDA in 2016 released new prescribing guidelines for opioids.

Opana ER was first approved in 2006 for the management of pain severe enough to require around-the-clock, long-term opioid treatment. The drug maker replaced the original version in 2012 with one reformulated to deter abuse, particularly by snorting. But the FDA says abuse of the drug shifted to injection and has since been associated with outbreaks of HIV, hepatitis C and a serious blood disorder.

“When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” Janet Woodcock, MD, director of the FDA’s Center for Drug Evaluation and Research, explained in a press release.

Opana ER represents just 5 percent of prescribed long-acting opioids, according to IMS Health, an information and technology company that serves the health care industry.

There are likely people with arthritis who take Opana ER for chronic pain and will be affected by the market withdrawal. A study published online in June 2017 in the journal Arthritis & Rheumatology found 41 percent of patients with rheumatoid arthritis regularly used prescription opioid pain medications and another 19 percent used them intermittently.

Donald Miller, professor and chair of pharmacy practice at North Dakota State University in Fargo says any patients regularly taking Opana ER should talk with their physicians now.

“I don’t think it will be too difficult to find an alternative for individual patients. What will happen is patients will switch to a similar drug at an equivalent or slightly lower dose and [adjust] their dose to pain relief on the new drug. The switch should go pretty smoothly for most people,” Miller says.

A conversation about replacing Opana ER should include considerations of nonopioid alternatives as well as nondrug methods proven to reduce pain, such as exercise and cognitive behavioral therapy.

Endo spokesperson Zoumas Lubeski stresses the removal of the medication isn’t a recall, but says that in addition to pulling it from the market, the company stopped manufacturing Opana ER immediately and no new product will be made.

“In order to enable time for patients currently taking Opana ER to work with their physicians to convert to an appropriate alternative treatment, Endo would only ship existing packaged finished product by no later than September 1, 2017,” she says.

The FDA says it will continue to examine the risks and benefits of all opioid pain medications and will take actions when it deems necessary to combat the epidemic.

Author: Jennifer Davis for the Arthritis Foundation

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One thought on “At FDA Urging, Drug Maker Pulls Opana ER Off Market

  1. This is a knee jerk reaction. Opana ER is a safe medication when taken as prescribed. Automobiles are safe when operated as designed. When driven carelessly, its deadly. Using the FDA’s logic, let’s take cars off the market.

    What about the patients who take Opana ER because other pain meds don’t work for them? I’ve had DNA Genomic testing done by my Pain Management Physician and my body does not process oxycodone or hydrocodone. The only pain medicine that has worked has been Opana ER and IR for breakthrough pain. I have a bad feeling about what my medical future holds in store.

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