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