Fentora: Death Climb after One Year on the Market-Incorrect Prescribing and Dosing Blamed

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

Fentora is not a generic version of Actiq. Therefore, do not directly substitute Fentora for Actiq or other fentanyl-containing products.

Fentanyl Buccal Tablets is marketed as Fentora manufactured by Cephalon, Inc. (which by the way has just been FDA approved for a new drug treatment for patients with indolent B-cell non-Hodgkin's lymphoma NHL).

A year later in September 2007 an FDA alert advises of reports received 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.

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 additional information on the safe use of Fentora.

Recommendations for the Fentora label and medication guide include:

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.

Place Fentora in your mouth against the gum and allow the tablet to dissolve. Do not chew or swallow the tablet.

If you were wrongly prescribed Fentora; if you or a loved one suffered severe life-threatening reactions because of Fentora; or if a loved one died because of being prescribed Fentora pain killer lozenge then you may qualify for a Fentora lawsuit against Cephalon, Inc., the makers of Fentora narcotic pain killer. Please contact Anapol Schwartz to find out what your legal options are.