FDA ALERT [9/2007]:  FDA 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. 

Recommendations

Healthcare professionals who prescribe Fentora should be fully aware of all the prescribing information in the product label.  Following are highlights of the important safety information from the product label:

• Fentora contains fentanyl, a very potent opioid analgesic, that may cause death if not used in opioid-tolerant patients exactly as instructed in the product label.
• Fentora should only be used for breakthrough pain in opioid-tolerant patients with cancer.  Patients considered physiologically opioid-tolerant are those who are taking at least 60 mg daily of oral morphine, at least 25 mcg/hour of transdermal fentanyl, at least 30 mg daily of oxycodone, at least 8 mg daily of oral hydromorphone, or an equianalgesic daily dose of another opioid for at least one week. 
• Do not prescribe Fentora for patients who only need an opioid on an intermittent, as needed basis and who are not on around-the-clock opioids.
• Do not prescribe Fentora for the management of acute or postoperative pain including headaches, migraines, and pain due to injury.  Life-threatening respiratory depression can occur at any dose of Fentora in opioid non-tolerant patients.  Deaths have occurred in opioid non-tolerant patients including patients who were given Fentora for headaches.
• Fentora dosing is complex and must be thoroughly understood before prescribing. 
  • At the same microgram (mcg) dose, Fentora results in higher blood levels of fentanyl than Actiq.  Therefore, for opioid-tolerant patients on around-the-clock opioids being treated with Actiq for their breakthrough cancer pain, conversion to Fentora MUST include a dose reduction according to the table in the product label.
  • For opioid-tolerant patients on around-the-clock opioids being treated with any other pain medication for their breakthrough cancer pain, the initial dose of Fentora is 100 mcg
  • During titration and after a dose has been selected, patients should never use more than 2 doses of Fentora to treat an episode of breakthrough cancer pain.  After the second dose of Fentora, patients must wait a minimum of 4 hours before treating another episode of breakthrough cancer pain with Fentora. 
• Fentora is not a generic version of Actiq.  Therefore, do not directly substitute Fentora for Actiq or other fentanyl-containing products.

Information for the patient: Physicians who are prescribing fentanyl buccal tablets should ensure that their patients or their caregivers understand the following:

• Fentora can cause life-threatening breathing problems which can lead to death if it is not used correctly.   Use Fentora exactly as prescribed by your doctor.
• Only take Fentora if you regularly use other opioid pain medicines around-the-clock (are opioid-tolerant).  Patients who take narcotic pain medications every day and around-the-clock develop tolerance, meaning that they are more resistant to the dangerous side effects of these medications including respiratory depression (severe trouble breathing), than patients who take narcotic pain medication only when needed.  Ask your healthcare professional if you are opioid-tolerant before taking Fentora.
• Only take Fentora for breakthrough pain due to cancer.  If this does not describe your situation, talk to your doctor about other options for managing your pain.  Fentora must not be used to treat pain from injuries, surgery, headaches or migraines.
• The Fentora dose prescribed to you may vary depending upon other opioid pain medicines you are receiving and the dose of these medicines.  Make sure you read, follow, and understand your doctor’s instructions and the Fentora Medication Guide for patients.
• Place Fentora in your mouth against the gum and allow the tablet to dissolve.  Do not chew or swallow the tablet.

Background Information

Since FDA approved Fentora in September 2006, FDA has received reports of serious adverse events including deaths in patients who received Fentora.  These reports describe inappropriate prescribing to non-opioid tolerant patients, misunderstanding of dosing instructions, and inappropriate substitution by pharmacists or prescribers of Fentora for Actiq.

Date created: September 26, 2007