Improper Use of Fentora Linked to Patient Deaths

Yael Waknine
Medscape Medical News 2007. © 2007 Medscape
September 14, 2007 — Serious adverse events, including death, have resulted from improper use of fentanyl buccal tablets (Fentora, Cephalon, Inc), the US Food and Drug Administration warned healthcare professionals yesterday.
The deaths were caused by improper patient selection (eg, opioid-intolerant patients), improper dosing, and/or improper product substitution for other drugs, according to an alert sent from MedWatch, the FDA's safety information and adverse event reporting program.
In a letter to healthcare professionals, the company emphasized the importance of adhering to certain prescribing guidelines to reduce the risk for respiratory depression.
Fentanyl buccal tablets are indicated only for the management of breakthrough pain in opioid-tolerant cancer patients. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphine/day, 25 µg transdermal fentanyl/hour, 30 mg oral oxycodone daily, 8 mg oral hydromorphone daily, or an equianalgesic dose of another opioid for a week or longer.
Opioid-intolerant patients and those with acute pain, postoperative pain, headache/migraine, or sports injuries should not receive this medication.
Because the buccal tablet formulation is distinct and not a generic version of fentanyl citrate transmucosal lozenges (Actiq, Cephalon), it should not be substituted for this or other fentanyl-containing products.
Dosing instructions should be carefully followed: no more than 2 fentanyl buccal tablets should be taken per episode of breakthrough pain, and 4 hours must elapse before treating the next episode.
For patients switching from fentanyl citrate therapy, a conversion table must be followed to select the initial dose: Those currently taking 200- or 400-µg lozenges should receive a 100-µg fentanyl buccal tablet, patients receiving a 600- or 800-µg lozenge should receive a 200-µg buccal tablet, and those taking 1200- or 1600-µg lozenges should receive a 400-µg buccal tablet.