Management on sanitary inspection behind quality of foodstuff and medicines (Food and Drug Administration, FDA) asked the pharmaceutical company Endo Pharmaceuticals to remove from sale a prolonged form of Oxymorphone. The drug is available under the trade name Opana ER. The reason for the request became more frequent cases of abuse of the drug.
“After careful consideration of the case, the Agency has requested to remove the tool from the market. The decision is based on the concern that use of the drug is probably no longer outweigh the risks”, — said in a statement the FDA.
Management took measures to deal with the sale of an existing opioid painkillers in the aftermath of the abuse of the drug for public health.
“We are faced with the opioid epidemic a public health crisis, and we must take all steps necessary to reduce the extent of incorrect use and abuse of opioids — according to Commissioner of Management Dr. Scott Gottlieb (Scott Gottlieb). — We will continue to regulate the market, if we see that there is a situation when the risks associated with opioids outweigh the benefits — not only for patients but also for those who use opioid painkillers by mistake or without medical prescription”.
The decision taken by the Management based on the analysis of post-marketing data. It turned out that after changing the formula of the drug Opana ER increased the number of cases of abuse of remedy. At the same time the abuse of Opana ER as injecting drug due to the increasing number of HIV infections and hepatitis C and also with the increase in the number of cases of clogging of small vessels by thrombi. All this was the cause of the request of withdrawal of product from sale.
The drug Opana ER was first registered in 2006 as a painkiller for patients with moderate and severe pain. The drug was designed for patients requiring round-the-clock pain relief for a long time. In 2012, the manufacturer changed the formula of Opana ER in the hope to make the drug resistant to physical and chemical manipulation and subsequent misuse through the nose or injected. However, the desired result has not been achieved.
The FDA asked the company Endo with a request to voluntarily withdraw the vehicle from sale. If the firm refuses to do this, Management will create a formal request to ban the trade in the drug.
Experts expect the FDA to continue to evaluate the ratio of “risk-benefit” of all reported opioid analgesics and, if necessary, to take measures aimed at combating the “opioid epidemic.”