FDA Seeks to Pull Pain Pill Off Market, Citing Risk of Abuse

Toni Houston
June 9, 2017

The U.S. Food and Drug Administration is asking Endo Pharmaceuticals Inc.to remove its Opana ER from the market over concerns about the painkiller's links to injection drug abuse, in what the agency called its first effort to remove an opioid pain drug from sale.

He has recommended new FDA policy that requires mandatory education on opioid abuse for healthcare professionals, limiting the number of doses a patient can be prescribed, and giving more scrutiny to new opioid drugs during their review. 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.

Endo said in a statement it's "reviewing the request and is evaluating the full range of potential options".

It's the first time the FDA has asked to pull an opioid pain drug from the market based on the public health consequences of its use.

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.

Abuse of Opana ER was blamed for a 2015 outbreak of HIV and hepatitis C in southern in linked to sharing needles.


The Centers for Disease Control and Prevention says opioid overdoses have hit record highs, killing more than 47,000 people in 2014 - more than the 32,000 who died in road accidents.

The FDA said Thursday that subsequent data showed a "significant shift" in the route of abuse "from nasal to injection" after the reformulation. It reformulated that drug in 2012 and claimed the changes made it harder to manipulate physically or chemically to abuse it. Endo tried to persuade FDA officials that the new formulation was abuse-resistant, which likely would have given the product a marketing advantage in the crowded, lucrative category of opioid painkillers. It also marks the first time that the US regulator that has sought to remove an opioid painkiller from the market over public safety concerns, Reuters noted.

As STAT has noted previously, Opana ER is meant to be swallowed and the contents released over 12 hours, which is known as extended release.

Cities and states have started suing makers of opioid drugs, saying that they've pushed their drugs on doctors and patients alike, helping drice addiction.

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

Those generic products might also face action by the FDA, which said it is "assessing the latest available data on abuse patterns".

Other reports by Ligue1talk

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