Fentora

Pain control can be one of the most difficult parts of treating a cancer patient. Chronic pain affects over fifty million Americans. There are two sub-categories of chronic pain; persistent and breakthrough pains. Persistent pain is consistent pain that lasts 12 or more days, and breakthrough pain is the flare of moderate to severe pain that is otherwise well-managed. Breakthrough pain occurs in sixty-four percent of cancer pain who have otherwise controlled persistent pain. When breakthrough pain occurs, it comes on very rapidly and can be pretty severe; however, its duration tends to be short (about thirty minutes).

Fentora is an opioid derivative medication that was developed and indicated for management of breakthrough pain in cancer patients. It is a pill that is placed between the cheek and the gum of the patient once the breakthrough pain comes on. It was first approved for use in September 2006. Cephalon, Inc is the manufacturer of Fentora. Their headquarters are in Pennsylvania but Fentora is manufactured in Salt Lake City.

On September 10, 2007, a letter was sent from the Food and Drug Administration and Cephalon, Inc. The letter was to warn healthcare professionals of the potential effects of prescribing Fentora outside of its intended use. Four people have died as result of Fentora being used incorrectly. One was a suicide, one person died because of incorrect dosing and two others died because they were prescribed the medication for headache pain. Therefore the letter noted that the deaths had occurred because of a failure to strictly follow instructions listed in the labeling of the product. Fentora should only be used for the management of breakthrough pain in those patients who are considered opioid tolerant.

Opioid tolerant is defined in relation to the prescribing of Fentora as the following:

• Patients who are receiving 60mg or more of oral morphine per day
• 25mcg or more of transdermal fentanyl per hour
• 30mg or more of oxycodone per day
• 8mg or more of oral hydromorphone per day
• Equianalgesic (having equal pain relief effect) dose of another opioid for a week or longer

On the other side, for those patients who do not require opioid therapy to the degree that is described above, they are considered “opioid non-tolerant” and should not be prescribed Fentora. Fentora should also not be prescribed for the management of post-operative pain. Nor should it be taken on a regular basis.

For more information regarding Fentora or if you have questions about how our medical legal consulting can help you with a case involving Fentora litigation, contact our offices at Medical Jurisprudence, Inc.