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FDA Asks Endo Pharmaceuticals to Pull Opana ER Painkiller from the Market

FDA Asks Endo Pharmaceuticals to Pull Opana ER Painkiller from the MarketBy now, we are all fully aware of the opioid crisis that is gripping our nation. We have written about it, looked at its sources, listened to the doctors and the patients affected, and tried our best to share the facts about drugs like fentanyl. We believe that standing up for patients is the right thing to do.

As it turns out, we’re not alone. In an extraordinary move, the Food & Drug Administration has asked Endo Pharmaceuticals to remove an opioid-based painkiller, Opana ER, from the shelves over concerns that the product may be leading to abuse. According to the Wall Street Journal:

“’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,’ FDA Commissioner Scott Gottlieb said in a statement. ‘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.’”

Aside from the more obvious risks involving opioid painkillers, Opana ER was linked to a 2015 outbreak of HIV and hepatitis C. Opioid addicts infected with the two diseases were sharing needles of the injectable painkiller. The Journal reports that Endo is “evaluating the full range of potential options as we determine the appropriate path forward.”

Drug overdoses are the leading cause of death of Americans under the age of 50

The FDA request may be the tipping point in this crisis. The New York Times’ recent investigation into drug-related deaths found that “Drug overdose deaths in 2016 most likely exceeded 59,000, the largest annual jump ever recorded in the United States.” According to the Times’ preliminary data, the majority of these deaths were related to “opioid addiction, now made more deadly by an influx of illicitly manufactured fentanyl and similar drugs.”

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Holding doctors and pharmaceutical companies, not victims, accountable

Opioid painkillers were designed to help people in acute pain. They have a useful and humane purpose and there is nothing wrong with that. The problem is that over and over again, we’re seeing medical professionals and pharmaceutical companies push incredibly strong opioid drugs like fentanyl as the only method for pain management.

The market has been flooded, and the uptick in prescriptions and abuse of Opioids since the early 2000s is staggering. Some of the doctors who push these drugs – like some of the pharmaceutical companies who push them to the doctors, or bribe them with “fees” – are absolutely complicit in the opioid abuse crisis.

At McGowan, Hood, Felder & Phillips, LLC, we are not going to stand by and let this go un-noticed. Our team of experienced dangerous drug attorneys in South Carolina represent clients in multiple states who have been hurt by negligent doctors or complicit drug companies. To learn more about our services, or to speak with an experienced lawyer, please call 803-327-7800, or fill out our contact form.