FDA Takes Unprecedented Step to Fight Opioid Crisis
FDA asks pharma company to take opioid painkiller off the market
By Michael Harthorne,  Newser Staff
Posted Jun 10, 2017 12:58 PM CDT
On Thursday, the FDA said it has asked Endo Pharmaceuticals to stop selling its reformulated, extended-release painkiller, Opana ER.   (AP Photo/Andrew Harnik, File)

(Newser) – The FDA is asking an Irish pharmaceutical company to take one of its pain medications off the market because of its contributions to America's opioid epidemic, USA Today reports. The FDA says it's the first time it's ever asked a company to withdraw an opioid pain medication "due to the public health consequences of abuse," according to NBC News. Endo International's Opana ER was first approved by the FDA in 2006; a reformulated version of Opana ER, meant to lessen the potential for abuse, was released in 2012. But the FDA, in an 18-8 vote, ruled the benefits of the reformulated version are outweighed by the risk of abuse, largely from crushing and injecting the drug. Endo argues its drug is both safe and effective.

Endo states it's evaluating the FDA's request. The company sold $158 million worth of Opana ER in 2015. The FDA states that if Endo doesn't voluntarily take Opana ER off the market, it will begin the process of withdrawing its approval of the drug. “I really did not think that the FDA would follow through,” says a woman who lost her 21-year-old son to an Opana overdose and later testified before the FDA. In addition to being linked to the growing opioid crisis in the US, Opana ER was blamed for an outbreak of HIV and hepatitis C in 2015 in Indiana, the AP reports. Approximately 2 million Americans are addicted to prescription opioids. According to the CDC, opioid overdoses killed more than 40,000 Americans in 2015—a record high.

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