| Hans-Günter Meyer-Thompson | International
USA. FDA requests removal of Opana ER for risks related to abuse
Today, the U.S. Food and Drug Administration requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. (...) The FDA’s decision is based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy).
(FDA News Release, 08.06.2017)
https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm562401.htm