The manufacturer of cancer pain medication Fentora has sent letters to doctors and health care professionals, stressing the need for correct patient selection, proper dosing, and appropriate administration of Fentora to reduce the risk of respiratory problems. In a Press Release, Cephalon, Inc. reported that it sent the warning letters “in response to recently reported serious adverse events, including some deaths in patients who were not appropriate candidates for Fentora.” A U.S. Food and Drug Administration (FDA) Safety Alert stresses that “Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.”
- Cephalon’s Letter to Doctors [PDF file]
- Cephalon’s Letter to Healthcare Professionals [PDF file]
- Cephalon Press Release on Fentora Warnings
- FDA Safety Information on Fentora
- Defective and Dangerous Products (FindLaw)
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