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Warning on Fentora Buccal Tablets

Posted on April 29, 2008

FDA is warning healthcare professionals about deaths and patient injuries from Fentora (fentanyl buccal tablets) a drug used to treat breakthrough cancer pain.

Some of these events occurred because the drug was prescribed for patients who should not have received it. Fentora should only be used for breakthrough pain in opioid-tolerant cancer patients who are already taking around-the-clock opioids. Life-threatening respiratory depression can occur if the drug is used in patients who are not opioid-tolerant, and so it should not be prescribed for acute or postoperative pain, migraines, headaches, or pain due to injuries.

Other adverse events occurred because the dosing instructions in the product labeling were not followed. The labeling states that if the breakthrough pain episode is not relieved within 30 minutes of the first dose, patients may take only one additional tablet of the same strength for that episode. If the breakthrough pain continues even after the second dose, no more Fentora may be used for that episode. In other words, patients should never take more than two doses of Fentora to treat an episode of breakthrough pain. And they must wait a minimum of four hours after the second dose before treating another episode of breakthrough pain.

Adverse events also occurred when prescribers or pharmacists substituted Fentora for Actiq without adjusting the dose. Actiq is an oral transmucosal product containing fentanyl, but its bioavailability is lower than Fentora. So Fentora cannot be substituted for Actiq on a mcg-for-mcg basis. In making the switch from Actiq to Fentora, the dose must be adjusted downward by following the table in the product label.

Additional Information:

FDA MedWatch Safety Alert. Fentora (fentanyl buccal tablet). September 13, 2007.
http://www.fda.gov/medwatch/safety/2007/safety07.htm#Fentora

FDA Press Release. FDA Warns of Potential Serious Side Effects with Breakthrough Cancer Pain Drug. September 26, 2007.
http://www.fda.gov/bbs/topics/NEWS/2007/NEW01711.html

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