Magazine article Drug Topics

How to Use Fentora Safely

Magazine article Drug Topics

How to Use Fentora Safely

Article excerpt

Femora (fentanyl buccal tablet), manufactured by Cephalon, received Food & Drug Administration approval on September 25,2006. Fentora is a potent opioid analgesic (C-II) indicated for the management of breakthrough pain in cancer patients who are tolerant to round-the-clock opioid therapy for persistent cancer pain. Since approval, the FDA has received reports of serious life-threatening side effects, including death, in patients who had taken Fentora for off-label uses, were not tolerant to opiate medications, or were not on concurrent round-the-clock opioid therapy. In addition, the FDA has received reports of patients who were prescribed the wrong dose, or were inappropriately administered Fentora in substitution for another fentanyl-containing product that is not equivalent to Fentora on a microgram for microgram (mcg/mcg) basis.

FDA issued a Public Health Advisory and a Healthcare Professional Sheet on September 26, 2007, to alert healthcare professionals and consumers about Fentora after receiving numerous adverse event reports concerning the incorrect use and misuse of the drug. FDA warned physicians and other healthcare professionals that it is critical to follow the instructions provided on the product labels when prescribing and administering Fentora.

The FDA further stated that it is dangerous to use Fentora for any short-term pain such as headaches or migraines. Fentora should not be used in patients who are not tolerant to round-the-clock opioid therapy. Patients must also be under a. doctors close supervision while taking Fentora. The dosing of Fentora must be carefully adjusted to control breakthrough pain adequately. Additionally, FDA warned against the improper substitution of Fentora, a quick-acting pain drug, for other pain medicines. Fentora is not the same as, or comparable to, other fentanyl products. Fentora must not be substituted on a mcg/mcg basis for Actiq, another fentanyl product, used to treat breakthrough cancer pain. A direct microgram substitution should not be done because Fentora delivers more fentanyl to the blood than Actiq, increasing the possibility of a fatal overdose.

We would like to highlight the following important safety information communicated in the Fentora Public Health Advisory:

* Fentora should only be used for breakthrough pain in patients with cancer who are tolerant to round-theclock opioid therapy. …

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