Drug Safety Alerts

Opana ER Discontinuation

7/12/2017

On July 12, 2017, Endo Pharmaceuticals announced that it has voluntarily agreed to discontinue its abuse-deterrent extended-release formulation of oxymorphone (Opana^® ER) from the US market, about a month after the United States Food and Drug Administration (FDA) asked the company to stop selling the pain medication.

The FDA’s request was based on a review of all available postmarketing data, which demonstrated a significant shift in the route of abuse of Opana ER from nasal to injection following the product’s reformulation. Injection abuse of reformulated Opana ER has been associated with a serious outbreak of HIV and hepatitis C, as well as cases of a serious blood disorder (thrombotic microangiopathy). The request followed a March 2017 FDA advisory committee meeting where a group of independent experts voted 18-8 that the benefits of reformulated Opana ER no longer outweigh its risks.

Endo will stop shipping Opana ER to wholesalers on September 1, 2017. After this date, product will only continue to be available until supplies are depleted. Endo believes this should help to minimize treatment disruption for patients and allow patients sufficient time to seek guidance from their healthcare professionals. Patients taking Opana ER should discuss alternate treatment options with their prescribing physician as soon as possible.

CVS/caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy will continue to dispense Opana ER until the supplies are depleted. At which time, patients will need to obtain new prescriptions to treat their condition.

For more information about this issue, health care providers may contact Endo Pharmaceuticals at 1-800-462-ENDO (1-800-462-3636) or visit www.endo.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1‑888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.