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Is There Potential Beyond Cancer Pain: Lessons
from Fentora
58
FDA FDA blocks blocks new new Fentora Fentorauses uses
September September 16, 16, 2008 2008
The The FDA FDA to to Cephalon: Cephalon: Get Get a better better risk-communication risk-communication program. program. That's That's what what
lies lies between between the the drugmaker drugmakerand and new new indications indications for for its its painkiller painkiller Fentora. Fentora. As As you you
know, know, Fentora Fentorais is already already emblazoned emblazoned with with warnings warnings of of potentially potentially life-threatening
life-threatening
risks. risks. Cephalon Cephalonhas has reported reported five five deaths deaths among among Fentora Fentorapatients, patients, from from adverse adverse
reactions reactions or or overdose. overdose.
Already Already approved approved for for breakthrough breakthrough cancer cancer pain, pain, Fentanyl Fentanylwas was up up for for FDA FDA
consideration consideration to to treat treat breakthrough breakthrough pain pain in in patients patients with with chronic chronic lower lower back back and and
nerve nerve pain. pain. But But an an advisory advisory panel panel voted voted 17-3 17-3 against against broadening broadening the the use use of of Fentora, Fentora,
citing citing the the potential potential for for misuse misuse among among even even more more patients. patients.
The The company company said said it it will will continue continue to to educate educate caregivers caregivers and and patients patients to to make make sure sure
the the drug drug is is appropriately appropriately prescribed--but prescribed--but offered offered no no other other word word yet yet on on how how it it plans plans to to
answer answer the the FDA's FDA's concerns. concerns. Though Though the the drug drug was was introduced introduced only only under under strict strict
guidelines guidelines for for use, use, in in its its some some two two years years on on the the market, market, scrips scripshave have grown grown to to
the the point point that that more more than than 80 80 percent percent of of patients patients take take it it off-label. off-label.
http://www.fiercepharma.com/story/fda-blocks-new-fentora-uses/2008-09-16
© Defined Health, 2009
Pain Insight Briefing