FDA seeks removal of opioid painkiller from the market

FDA seeks removal of opioid painkiller from the market

The withdrawal marks the first time the agency taken steps to remove an opioid pain medication due to the public health implications and comes amid an intense national debate about the abuse of opioids.

Although a reformulated version of Opana ER had been approved in 2013 to discourage its abuse, people abusing the drug simply changed from inhaling it to injecting it, which led to serious outbreaks of HIV and Hepatitis C, the statement said.

In March a panel of advisers to the FDA voted 18-8, with one abstention, that the drug's benefits no longer outweighed the risks. As opioid abuse continues to take a heavy toll on communities in IN and across the country, we must take steps to confront this public health epidemic. As a result, some who abuse Opana ER are injecting the drug more frequently. Endo shares, which were up 11 percent at the close of the stock market, fell more than 12 percent in after-hours trading. "When we determined that the product had risky 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 said in the FDA's prepared statement.

FDA requests removal of Opana ER for risks related to abuse [news release].

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Endo has had other issues with the FDA and the drug.

The FDA will continue to examine the risk-benefit profile of all approved opioid analgesic products and take further actions as appropriate as a part of our response to this public health crisis.

"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak", said Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research.

"When we determined that the product had risky unintended consequences, we made a decision to request its withdrawal from the market", Woodcock added in a statement.

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The company, attempting to fight drug abuse, claimed to have reformulated the drug so that it could not be crushed or molded for snorting or injection.

USA regulators want a narcotic painkiller involved in the opioid epidemic off the market.

Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns". However, the company came under fire from both the FDA and the state of NY for not making significant changes that reduced the risk of abuse. But the Philadelphia area pharmaceutical company said in a statement that it's reviewing the FDA's request "and is evaluating the full range of potential options" before it decides on the best path to take forward.

Randall Stanicky, an analyst at RBC Capital Markets, said Opana ER is a declining asset whose sales are expected to fall to US$97 million in 2019, down from an estimated US$134 million in 2017.

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