"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 Gottlieb in a news release.
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. Increased needle-sharing of the drug has since been linked to serious blood disorder cases in Tennessee in 2012 and a 2015 outbreak of HIV and hepatitis C in IN, officials said.
An FDA advisory committee voted in March that Opana ER's benefits no longer outweighed its 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. Opana ER is one of a group of drugs that makes up Endo's pain category which had sales of $486 million for the 12 months of 2016. On Thursday, June 8, 2017, the FDA said it has asked Endo Pharmaceuticals to stop selling its reformulated, extended-release painkiller, Opana ER.
Endo, which has its USA headquarters in Malvern, said it was reviewing the request and "evaluating the full range of potential options".
Endo first got USA approval for its extended-release opioid, Opana ER, in 2006. If the company does not choose to do so voluntary, the FDA will force the issue by withdrawing its approval for the drug.
FDA officials said their decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of the reformulated product from nasal to injection following the product's reformulation.More news: Bangladesh suffer woeful warm-up for Champions Trophy opener
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The FDA indicated that if Endo declines to remove Opana ER voluntarily, the agency would withdraw approval for the opioid.
"When we determined that the product had risky and unintended consequences, we made a decision to request its withdrawal from the market", Woodcock said. Most claim the drugmakers oversold the benefits and downplayed the risks in their marketing of the drugs to the public and doctors.
"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak", said Dr. Janet Woodcock, director of the FDA's Center for Drug Evaluation and Research. The agency said it would take formal action to remove the product from market if Endo Pharmaceuticals denies the FDA's request.
Drug overdose deaths have been on the rise in the U.S., with opioid overdoses accounting for more than 33,000 deaths in 2015, according to the U.S. Centers for Disease Control and Prevention.
In addition, the FDA said it will continue to look at the risks versus the benefits of all other opioid painkillers on the market and take further action if needed.
Last year, Opana ER generated almost $159 million in revenue, although sales have slowed more recently.