The U.S. Food and Drug Administration (FDA) released a first time ever request targeting Endo Pharmaceuticals and its Opana ER opioid pain medication. FDA’s decision to ask for the removal of this product is reportedly based on the drug’s potential overuse and abuse.
Opana ER Is a Powerful Opioid Painkiller Which Could Easily be Overused
The FDA announced its decision to request the removal of the opioid painkiller through a statement released on June 08. In it, the administration also offered an explanation and laid out the basis of its request.
According to it: “After careful consideration, the agency is seeking removal based on its concern that the benefits of the drug may no longer outweigh its risks.”
This statement continues by pointing out that this is the first time ever that the FDA decided to take such a step. Still, as stated above, the agency considers that the drug’s potential abuse overrides its benefits at this point.
The request that Endo pull Opana ER off the market comes as the U.S. is facing a national opioid crisis. In a previous statement, the federal Department of Health and Human Services described the current situation as an “unprecedented opioid epidemic”.
Opana ER or oxymorphone hydrochloride is sold by Endo Pharmaceuticals, an Ireland-based pharmaceutical company. Headquartered in Dublin, the firm has a U.S. base in Malvern, Pennsylvania.
This opioid painkiller is usually prescribed as the patient needs a long-term medication. Currently, Endo is selling a reformulated Opana ER. This change should reportedly help curb the potential for its abuse.
Following the FDA’s request, Endo released a statement of its own regarding the situation. In it, the company declared that it will be evaluating the request and also the “full range of potential options”. It will be doing so as it will try to determine the “appropriate path forward”.
Some suggest adding an extra set of restrictions, which should help prevent the abuse of Opana ER. In its statement, the FDA mentioned that if Endo does not meet its request, it will proceed in withdrawing the approval for Opana ER.
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