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Fentora
Fentora is a pain-relief medication that contains Fentanyl Buccal, an opioid analgesic, first synthesized by Janssen Pharmaceutica (Belgium) in the late 1950s, with a potency eighty times that of morphine. This medication is used to treat moderate-to-severe sudden (breakthrough) cancer pain in those patients who may have become opioid-tolerant.
In September 2007, the federal Food and Drug Administration became concerned that Fentora was being mis-prescribed and misused. Therefore they urged Cephalon, the manufacturer of Fentora, 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 and death.
Fast Facts
| Name: | Fentora |
| Generic: | Fentanyl Buccal Tablet |
| Manufacturer: | Cephalon |
| Date approved: | September 25, 2006 |
| Status: | Prescription Only |
| Approved uses: | Indicated 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. |
| Off-Label uses: | None |
| Side effects: | Nausea, vomiting, constipation, lightheadedness, dizziness, drowsiness, or headache may occur. |
| Related topics: | OxyContin |
FDA Publishes New Important Warnings Regarding Fentora
Recently, the federal Food and Drug Administration has received reports of serious side effects including death in patients who have taken Fentora. These reports describe prescribing to... read more
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