To combat the growing threat of abuse of opioid management for quality control of the US Food and Drug Administration (FDA) has issued an order to withdraw from the sale of an opioid analgesic is oxymorphone hydrochloride (oxymorphone hydrochloride), manufactured by Endo International Plc.
As noted in statement American regulator, this is the first case in which the FDA experts have decided to withdraw from the market of an opioid analgesic in order to avoid the problems of public health and health-related consequences of drug abuse.
It is reported that the FDA decision is based on an analysis of available data showing a significant increase in drug abuse rates for intravenous use, and follows the conclusion of the FDA advisory committee that the benefits of the drug no longer outweigh the risks. The drug was also associated with a serious outbreak of HIV infection, hepatitis C and the development of thrombotic microangiopathy, the regulator said.
As the head of the FDA Scott Gottlieb, faced with an opioid epidemic, we are obliged to take all necessary steps to reduce the scale of misuse and abuse of opioids. According to him, the FDA will continue to take measures to regulate opioid analgesics not only if the risks of using the drug outweigh the benefits, but also in the case risk of abuse.