The FDA to Cephalon: Get a better risk-communication program. That's what lies between the drugmaker and new indications for its painkiller Fentora. As you know, Fentora is already emblazoned with warnings of potentially life-threatening risks. Cephalon has reported five deaths among Fentora patients, from adverse reactions or overdose.
Already approved for breakthrough cancer pain, Fentanyl was up for FDA consideration to treat breakthrough pain in patients with chronic lower back and nerve pain. But an advisory panel voted 17-3 against broadening the use of Fentora, citing the potential for misuse among even more patients.
The company said it will continue to educate caregivers and patients to make sure the drug is appropriately prescribed--but offered no other word yet on how it plans to answer the FDA's concerns. Though the drug was introduced only under strict guidelines for use, in its some two years on the market, scrips have grown to the point that more than 80 percent of patients take it off-label.
- read the story in the Philadelphia Inquirer