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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 non-opioid-tolerant patients, misunderstanding of dosing instructions, or inappropriate substitution of Fentora for Actiq by pharmacists and prescribers. The directions for using Fentora must be followed exactly to prevent death or other severe side effects from overdosing with fentanyl. FDA has asked Cephalon, the manufacturer of Fentora, to update the Fentora label and Medication Guide for patients with additional information on the safe use of Fentora.

In addition, tCephalon published a "Dear Healthcare Professional Letter" along with other warnings. The text of the letter is as follows:

September 10,2007

Dear Doctor:

We are writing to inform you about key safety -information regarding the use of FENTORA (fentanyl buccal tablet) [C-11]. We have recently learned of serious adverse events, including deaths 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 following information is meant to emphasize key points about appropriate patient selection and proper dosing and administration of FENTOM to reduce the risk of respiratory depression.

Key Safety Information regarding FENTORA:

  • Do NOT use FENTORA in opioid non-tolerant patients
  • Use FENTORA only for labeled indications
  • Do not prescribe FENTORA for patients with acute pain, postoperative pain, headache, migraine, or sports injuries
  • FENTORA is not a generic version of Actiq. Therefore, do NOT substitute FENTORA for Actiq or other fentanyl-containing product
  • Follow dosing instructions carefully:
    • For unrelieved breakthrough pain (BTP), patients should NOT take more than 2 FENTORA tablets per BTP episode
    • Patients MUST wait at least 4 hours before treating another BTP episode with FENTORA 
Please educate your patients as to the importance of following these instructions carefully.

We have revised the patient selection criteria and dosing instructions for FENTORA, and will be updating our package insert shortly. Please read the following information about FENTORA thoroughly.

Patient Selection

Do not prescribe FENTORA to patients who are opioid non-tolerant (i.e., patients who are not taking around-the-clock opioids). Do not prescribe FENTORA for patients with acute pain, postoperative pain, headachelmigraine, or sports injuries, even if they are suitable for receiving other opioids on an as needed basis (PRN).

FENTORA is indicated only for the management of breakthrough pain (BTP) in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain. Patients considered opioid tolerant are those who are taking at least 60 mg oral morphinelday, at least 25 mcg transdermal fentanylhour, at least 30 mg of oral oxycodone daily, at least 8 mg oral hydromorphone daily or an equianalgesic dose of another opioid for a week or longer.

Do not substitute FENTORA

Do not substitute FENTORA for Actiq or other fentanyl-containing products. The dosage strength of fentanyl in FENTORA is not equivalent to the same dosage strength of fentanyl in other fentanyl-containing products. FENTORA is a distinct formulation of fentanyl and is NOT a generic version of Actiq. When switching a patient from Actiq to FENTORA, physicians must follow instructions found in the prescribing information as Actiq and FENTORA are not equivalent on a microgram per microgram basis.

Thank you for taking the time to read this important safety information on FENTORA. Cephalon is committed to providing healthcare professionals with useful information to guide the safe and appropriate use of its products. Before prescribing FENTORA, please review the enclosed full prescribing information, including boxed warning. In addition, inform your patients of the availability of a Medication Guide and instruct them to read the Medication Guide with each prescription prior to taking FENTORA.

If you have any questions, please contact Cephalon Medical Services at 1-800-896-5855 and we will be glad to assist you. Thank you.


Sincerely,
Jeffrey M. Dayno, M.D.
Vice President
Medical Services

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