Why the FDA Wants Opioid Opana ER Pulled From Market

Roni Shye
Roni Shye, PharmD BCGP BCACP, is a licensed pharmacist in the states of Florida, Ohio, and Pennsylvania.
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With concerns over opioid use at an all-time high in the US, the FDA has started re-evaulating the risks vs benefits of some pain relief medications.

Now, the FDA is asking the manufacturer of Opana ER, Endo Pharmaceuticals, to remove Opana ER from the market due to concerns that the benefit of the medication may no longer outweigh its risks.

What is Opana ER?

Opana ER (oxymorphone) is a narcotic pain medication used for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic (pain reliever) is needed for an extended period of time.

When was Opana ER approved by the FDA?

The original approval of Opana ER was in 2006, but Opana ER was reformulated by the manufacturer in 2011.

Why was Opana ER reformulated?

In 2011, Endo Pharmaceuticals replaced the original formulation of Opana ER by adding INTAC technology with the hope of making it more resistant to potential abuse.

The reformulation was intended to make the drug more resistant to physical and chemical manipulation for abuse by snorting or injecting. However, it was determined by the FDA that the reformulation did not meaningfully reduce abuse, and therefore could not be labeled as abuse-deterrent.

Why is the FDA asking for Opana ER to be taken off of the market now?

The FDA has evaluated Opana ER, and expressed concern that its benefits may no longer outweigh its risks.

How did the FDA come to this conclusion?

The FDA’s decision is based on a review of all available post-marketing data, which showed a significant shift in the route of abuse of Opana ER, from snorting nasally to injection, following the product’s reformulation.

This decision follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18 – 8 that the benefits of reformulated Opana ER no longer outweigh its risks.

Have there been consequences of the increased Opana ER injection abuse?

Injection abuse of reformulated Opana ER has been associated with an outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).

What is the intended result of the FDA taking Opana ER off the market?

The removal of Opana ER from the market will protect the public from further potential for misuse and abuse of this product.

What if Endo Pharmaceuticals does not want to remove Opana ER from the market?

If Endo Pharmaceuticals does not agree to remove Opana ER from the market, the FDA will formally require removal by withdrawing its approval.

Is the FDA going to start targeting other pain medications and requesting their removal from the market?

The FDA has stated that they will continue to examine the risk-benefit profile of all approved opioid analgesic products, and take further actions as appropriate. It’s possible that other medications may receive a similar evaluation in the future.

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