HomeWhat's New AnnouncementIn A First, FDA Requests An Opioid Be Pulled From The Market

In A First, FDA Requests An Opioid Be Pulled From The Market

Summary: FDA Removes Opioid From the Market: In what may be the first of many such moves, the FDA has announced that it is removing a prescription opioid painkiller, Opana ER, from the market due to concerns over its potential for abuse.

According to the FDA Press Release, the manufacturer replaced the original formulation of Opana ER in 2012 with a new formulation intended to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. While the product met the regulatory standards for approval, the FDA determined that the data did not show that the reformulation could be expected to meaningfully reduce abuse and declined the company’s request to include labeling describing potentially abuse-deterrent properties for Opana ER.  “When we determined that the product had dangerous unintended consequences, we made a decision to request its withdrawal from the market,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

To read the FDA’s news release, click here.