FDA Wants Opana ER Pulled Off Pharmacy Shelves

David Donald

The United States Food and Drug Administration is taking steps for the first time in history to remove an opioid from the market to combat abuse.

“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,” said FDA commissioner Scott Gottlieb, M.D., in a press release  “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.”

In 2012, Endo Pharmaceuticals reformulated Opana ER with a coating to discourage abusers from crushing up the pills and snorting them.

While the coating deterred many people from snorting it, it also led to an increase of people to abuse the drug by injection. Drug abusers who injected the drug also shared their needles, which has led to an outbreak of HIV, Hepatitis C and a serious blood disorder called thrombotic microangiopathy, according to the FDA.

In response to the FDA’s request, Endo Pharmaceuticals said it would review the request and evaluate their “potential options as they determine their path forward.” Endo Pharmaceuticals also maintained that Opana ER is safe if patients use it as prescribed.

People who suffer from back pain are at risk of developing an addiction to an opioid.

About 31 million Americans will experience low back pain at any given time, according to American Chiropractic Association. Back pain is one of most common reasons for missing work, and most will visit a doctor for their pain.

Nearly 40 percent of participants in a recent NPR-Truven Health Analytics Poll said their doctor recommended painkillers over nondrug therapies to treat pain in the lower back.

The BioSpine Institute has a clear stance when it comes to prescribing opioids to treat back pain: opioids are a band-aid solution; they do not solve the underlying condition causing the back pain and come with the risk of addiction.

After conservative treatments have failed, minimally invasive spine surgery is often the only solution left to relieve or reduce back pain. The only time we prescribe pain medications is for post-surgery recovery, and many of our patients never need them, preferring over-the-counter medications like Tylenol or Advil instead.

Pulling Opana ER off the market would help to combat the rising epidemic of opioid abuse in the United States, forcing physicians to concentrate more on treating the condition rather than the symptoms of pain.  

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