FDA to evaluate opioid drug safety

The FDA has notified the manufacturers of certain opioid drug products that these drugs will be required to have a Risk Evaluation and Mitigation Strategy (REMS) to ensure that the benefits of the drugs continue to outweigh the risks of use in specific patients. The affected opioid drugs include brand and generic products formulated with the active ingredients fentanyl (Duragesic, from Ortho-McNeil Janssen), hydromorphone, methadone (Dolphine, from Roxane), morphine (Avinza, from King Pharmaceuticals; Kadian, from Actavis; MS Contin, from Purdue Pharma; Oramorph SR, from Xanodyne Pharmacal), oxycodone (OxyContin, from Purdue Pharma), and oxymorphone (Opana ER, from Endo Pharma).

For more information visit www.fda.gov/Drugs/DrugSafety/InformationbyDrugClass/ucm163647.htm.