FDA Warning: Potential Serious Side Effects of Fentora (fentanyl buccal)

Filed in archive Cancer , Consumer Alert , Treatment on September 27, 2007

Manufactured by Cephalon, Inc - Fentora (fentanyl buccal) - was approved by the FDA 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 in September 2006.




Now, the FDA has recently issued a warning, alerting health care professionals and consumers of Fentora's potential serious side effects and reports of death as the result of improper selection of patients, dosing, or improper product substitution.

On Sept.10, 2007, Cephalon Inc., the manufacturer of Fentora, sent letters to physicians and other health care providers advising them about the adverse events and deaths reported for Fentora.

FDA is reviewing available information including adverse events. The agency has asked the company to strengthen warnings and improve the dosing instructions in the drug's product labeling.

FDA also requested that the company improve their education plan for prescribers and pharmacists on the proper patient selection, dosing instructions and restrictions on substituting Fentora for other products.

May this be a reminder to all patients to refrain from modifying the dosage prescription of your doctor in any medication.

Find more details from the FDA News.

[Photo Credit: Prescribing Reference]