FDA to evaluate opioid drug safety

The FDA has notified the manufacturers of certain opioiddrug products that these drugs will be required to have a Risk Evaluation andMitigation Strategy (REMS) to ensure that the benefits of the drugs continue tooutweigh the risks of use in specific patients. The affected opioid drugsinclude brand and generic products formulated with the active ingredientsfentanyl (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.