'Dear Doctor' warning issued on risks of
buccal fentanyl.
by Mechcatie, Elizabeth
The manufacturer of the buccal formulation of fentanyl is notifying
health care professionals about serious adverse events, including
deaths, that have been reported in patients treated with the opioid
analgesic drug, a result of improper patient selection and other
factors.
A "Dear Healthcare Provider" and a "Dear
Doctor" letter were issued by Cephalon Inc. and posted on the Food
and Drug Administration's MedWatch Web site in September. Cephalon
markets fentanyl buccal tablets under the trade name Fentora, an opioid
agonist that is a schedule II controlled substance. Fentora is approved
only for the management of breakthrough pain in patients with cancer who
are already receiving and who are tolerant to opioid therapy for their
underlying persistent cancer pain.
Use in opioid-nontolerant patients is among the causes of deaths in
patients treated with Fentora. In addition to improper patient
selection, deaths have resulted from improper dosing and/or improper
product substitution, according to the letters, which emphasized that
Fentora should be used only for the indications in the label and only in
patients taking round-the-clock opioids. Fentora should not be
prescribed for patients with acute pain, postoperative pain,
headache/migraine, or sports injuries.
The letters also state that Fentora is not a generic version of
Actiq, and should not be substituted for Actiq or other products
containing fentanyl. Actiq is the trade name for oral transmucosal
lozenges containing fentanyl.
Prescribers are urged to follow the dosing instructions carefully:
Patients with unrelieved break through pain should not take more than
two Fentora tablets per episode, and patients should wait at least 4
hours before treating another breakthrough episode of pain with Fentora.
Health care providers with further questions can contact Cephalon
at 800-896-5855.
The MedWatch summary, letters, and label with medication guide are
available at www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora.
COPYRIGHT 2007 International Medical News
Group Reproduced with permission of the copyright holder. Further reproduction or distribution is prohibited without permission.
Copyright 2007 Gale, Cengage Learning. All rights
reserved. Gale Group is a Thomson Corporation Company.
NOTE: All illustrations and photos have been removed from this article.