Endo International PLC has voluntarily opted to withdraw its Opana ER (oxymorphone hydrochloride extended release) product from the market after a U.S. Food and Drug Administration request in June, following a thorough review period and collaboration with the agency.
Regardless of Endo’s continuing conviction that Opana ER is safe and effective when used as directed, the company decided to comply based on potential abuse of the drug, an opioid agonist prescribed for severe pain in lieu of failed alternative medications.
Spokespersons clarified that Endo remains “confident” in data supporting the product’s integrity and that its willingness to remove Opana ER from marketing does not mean that the company believes the medication unsafe. The company offers plentiful information about potential interactions, side effects, contraindications, warnings and precautions.
For example, patients with respiratory or pulmonary conditions, strong previous reactions to oxymorphone, impaired liver function or serious gastrointestinal conditions are not considered candidates for the medication.
Likewise, combining Opana ER with alcohol or benzodiazepines can lead to respiratory depression and sedation. Patients who are elderly, weakened from cachexia or otherwise debilitated; or who have seizure disorders or substance abuse histories, are at higher risk for complications from this product.