FDA Issues Public Health Advisory for Fentora

Yael Waknine

September 26, 2007 — The US Food and Drug Administration has issued a public health advisory today to alert healthcare professionals and consumers regarding reports of life-threatening and sometimes fatal events in patients receiving fentanyl buccal tablets (Fentora, Cephalon, Inc).
These events were associated with improper patient selection (eg, opioid-intolerant patients or patients who did not have cancer), improper dosing (incorrect dose or dose too high), and/or improper product substitution for nonequianalgesic fentanyl-containing products.
Physicians and other healthcare professionals are strongly advised to follow product labeling when prescribing fentanyl buccal tablets to minimize the risk for respiratory depression.
Fentanyl buccal tablets are indicated only for the management of breakthrough pain in opioid-tolerant cancer patients. Patients considered physiologically opioid tolerant are those who have been taking at least 60 mg of oral morphine per day, 25 µg of transdermal fentanyl per hour, 30 mg of oral oxycodone daily, 8 mg of oral hydromorphone daily, or an equianalgesic dose of another opioid for 1 week or longer.
Opioid-intolerant patients and those with acute pain, postoperative pain, headache/migraine, or sports injuries should not receive this medication.
Patients must be under a physician's care and be closely supervised during treatment. In addition, physicians should make careful dose adjustments for breakthrough pain, according to an alert sent today from MedWatch, the FDA's safety information and adverse event reporting program.
Because the buccal tablet formulation results in higher blood levels of fentanyl, conversion from fentanyl citrate transmucosal lozenges (Actiq, Cephalon) must include a dose reduction. Treatment with 200- or 400-µg lozenges is equivalent to a 100-µg fentanyl buccal tablet, a 600- or 800-µg lozenge is equivalent to a 200-µg buccal tablet, and treatment with a 1200- or 1600-µg lozenge is equivalent to a 400-µg buccal tablet.
For opioid-tolerant patients receiving any other around-the-clock opioids for breakthrough cancer pain, the initial dose for fentanyl buccal tablets is 100 µg. During titration and after dose selection, no more than 2 fentanyl buccal tablets should be taken per episode of breakthrough pain and 4 hours must elapse prior to treating the next episode.
Healthcare professionals and patients/caregivers should be aware of symptoms associated with fentanyl overdose that require immediate medical attention, such as trouble breathing or shallow breathing; tiredness; extreme sleepiness or sedation; inability to think, talk, or walk normally; and feeling faint, dizzy, or confused.