Fda asks drugmaker to stop selling its opioid painkiller
The FDA has asked a drugmaker to stop selling its opioid painkiller, citing concerns over its potential for abuse and addiction.
The drug in question is a prescription painkiller called Opana ER, which is manufactured by Endo Pharmaceuticals. The FDA has asked Endo to withdraw the drug from the market due to its high potential for abuse and addiction, as well as the risk of overdose and death.
Opana ER is a controlled-release formulation of the opioid painkiller oxymorphone, which is designed to provide long-lasting pain relief for patients with severe chronic pain. However, the FDA has determined that the benefits of the drug no longer outweigh the risks, particularly in light of the ongoing opioid epidemic.
The FDA's decision is based on a review of data from the drug's clinical trials, as well as reports of abuse and overdose associated with the drug. The agency has also received reports of patients who have developed opioid use disorder after taking Opana ER.
Endo Pharmaceuticals has agreed to withdraw Opana ER from the market, and the company has begun the process of discontinuing the drug. The FDA has also asked Endo to conduct a post-marketing study to assess the risk of abuse and addiction associated with the drug.
The FDA's decision to ask Endo to stop selling Opana ER is part of a broader effort to address the opioid epidemic, which has been linked to more than 47,000 deaths in the United States in 2017 alone. The agency has taken a number of steps in recent years to address the issue, including approving new treatments for opioid use disorder and working with drugmakers to develop safer opioid formulations.
In a statement, the FDA said that it is committed to taking a comprehensive approach to addressing the opioid epidemic, and that it will continue to work with drugmakers, healthcare providers, and patients to ensure that patients have access to safe and effective treatments for pain while minimizing the risk of abuse and addiction.
The FDA's decision to ask Endo to stop selling Opana ER is a significant step forward in addressing the opioid epidemic, and it is likely to have a major impact on the pharmaceutical industry and the healthcare community.