The FDA has asked Endo Pharmaceuticals to take its reformulated oxymorphone product Opana ER off the market.
This article first appeared June 08, 2017 on Medpage Today.
By John Gever
WASHINGTON -- The FDA said Thursday that it has asked Endo Pharmaceuticals to take its reformulated oxymorphone product Opana ER off the market.
"After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks," the agency said in announcing the move. "This is the first time the agency has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse."
In Thursday's action, the FDA said it was asking Endo to voluntarily cease marketing Opana ER. But it added that if the company refuses, the agency will "take steps to formally require its removal by withdrawing approval."
The FDA said its data indicate that the abuse of the drug has shifted from snorting to injection following reformulation in 2012, which was intended to help the pills resist physical and chemical manipulation. However, the agency had declined to allow Endo to market the product as abuse-resistant.
Subsequently, Opana ER was associated with a notorious outbreak of HIV and hepatitis C infection in rural Indiana two years ago, caused by needle-sharing among opioid addicts.
"The abuse and manipulation of reformulated Opana ER by injection has resulted in a serious disease outbreak. When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market," said Janet Woodcock, MD, director of the FDA's Center for Drug Evaluation and Research, in a statement. "This action will protect the public from further potential for misuse and abuse of this product."
An advisory committee had voted 18-8 in March that the product's benefits do not outweigh its risks.