FDA Asks Endo to Withdraw Opana ER Opioid

(Reuters)—The U.S. Food and Drug Administration said on Thursday it has asked Endo International to withdraw from the market its long-lasting opioid painkiller Opana ER, sending the company’s shares down as much as 13%.

“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 a statement.¹

It is the first time the agency has taken steps to remove an opioid pain medication due to the public health implications of abuse.

Reference

1. U.S. Food and Drug Administration. News release: FDA requests removal of Opana ER for risks related to abuse. 2017 Jun 8.