![]() ![]() According to the American Society for Addiction Medicine (ASAM), in 2016 two million Americans were addicted to prescription painkillers – four times the number who were using heroin. ![]() They are widely prescribed for chronic pain, and their addictive nature all too often leaves patients hooked. Prescription painkiller misuse is part of a much wider opioid problem in the US. If the company refuses to voluntarily withdraw the product, it says it will start the process to formally withdraw its marketing authorisation.Įndo says it is ‘reviewing the request and is evaluating the full range of potential options’, adding that it remains confident that the product has a favourable risk–benefit profile when used as intended in appropriate patients. The FDA has now determined that the reformulation didn’t have the desired effect. The drug had been on the market since 2006 as a long-lasting analgesic, and Endo reformulated it in 2012 to make it more resistant to abuse by snorting or injection. The decision came in the light of a realisation that abuse of Opana ER was shifting from nasal administration to injection, increasing the risks of thrombotic microangiopathy and the transmission of viral infections such as HIV and hepatitis C. The FDA decided that its benefits do not outweigh the risks, and represents the first time the agency has asked for an opioid to be withdrawn because of concerns that it might be abused. The US Food and Drug Administration (FDA) has asked Endo Pharmaceuticals to withdraw its extended relief opioid pain medication, Opana ER (oxymorphone) from the market. Endo is reviewing the FDA’s request to remove Opana from the market. ![]()
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