FDA safety page: How to use Fentora safely

April 14, 2008

Here are highlights of important safety information regarding Fentora

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 doctor's 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.

The Fentora product labeling and Medication Guide have been updated to include this new safety information. As the pharmacist, you should familiarize yourself with Fentora's approved indication of use, dosing, and administration to ensure its safe use. Be aware that there are specific dose conversion recommendations stated in the package insert labeling for switching a patient from Actiq to Fentora. Be alert to off-label use of the product (e.g., acute pain, migraine headaches), prescribing to patients who are not tolerant to round-the-clock opioid therapy, etc.), and follow up with the prescriber if necessary. Finally, counsel patients on the proper use and administration of Fentora.

If you become aware of medication errors or other adverse events involving Fentora or other products, please report them to the FDA MedWatch program online at http://www.fda.gov/medwatch/.

LORETTA HOLMES is a Safety Evaluator and Carol Holquist is Director in the Division of Medication Error Prevention, The Office of Surveillance and Epidemiology at the FDA.