FDA wants opioid pulled from market due to risk of abuse June 21, 2017 General Food and Drug Administration, Prescription Drugs, Drug Abuse, Opioids 0 Last week, the U.S. Food and Drug Administration (FDA) requested that Endo Pharmaceuticals remove its opioid pain medication, reformulated Opana ER (oxymorphone hydrochloride), from the market. After careful consideration, the agency is concerned that the benefits of the drug may no longer outweigh its risks. This is the first time the FDA has taken steps to remove a currently marketed opioid pain medication from sale due to the public health consequences of abuse. The FDA’s decision is based on a review of all available data and follows a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks. Opana ER was first approved in 2006 for the management of moderate-to-severe pain when a continuous, around-the-clock opioid analgesic is needed for an extended period of time. It was reformulated in 2012 in an attempt to make the drug resistant to physical and chemical manipulation for abuse by snorting or injecting. Postmarketing data has shown, however, 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). “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, M.D., director of the FDA’s Center for Drug Evaluation and Research. “This action will protect the public from further potential for misuse and abuse of this product.” The FDA has requested that the company voluntarily remove reformulated Opana ER from the market. Should the company choose not to remove the product, the agency intends to take steps to formally require its removal by withdrawing approval. In the interim, the FDA is making health care professionals and others aware of the particularly serious risks associated with the abuse of this product. For more information about preventing opioid abuse, see the California Medical Association's safe prescribing resource page at www.cmanet.org/safe-prescribing. Comments are closed.
