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'Dear Doctor' warning issued on risks of buccal fentanyl.

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
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Title Annotation:Neurology
Author:Mechcatie, Elizabeth
Publication:Internal Medicine News
Date:Nov 15, 2007
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