Fentora (fentanyl buccal tablet)
Audience: Pain management
specialists, other healthcare professionals
From www.FDA.gov
By The Federal Drug Administration
September 13, 2007
[Posted 09/13/2007] Cephalon issued two Dear Healthcare Professional Letters
to inform prescribers and other healthcare providers of important safety
information regarding Fentora. 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. Serious adverse events, including deaths, have occurred in patients
treated with Fentora. These deaths occurred as a result of improper patient
selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or
improper product substitution. The healthcare professional letters provide
key points regarding appropriate patient selection and proper dosing and
administration of Fentora to reduce the risk of respiratory depression.
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