FDA Warning: Cancer Pain Medication Fentora May Cause Side Effect Including Death

According to two warning letters (warning letter 1, warning letter 2) the US Federal Drug Administration is warning about adverse effects that Fentora (fentanyl buccal tablets) is causing in patients who are taking this drug. Serious adverse side effects have seen for Fentora including the death of patients.

Fentora (fentanyl buccal tablets ) is a drug for breakthrough pain in cancer patients who are opioid tolerant.

FDA says that death have occurred because of "a result of improper patient selection (e.g. use in opioid non-tolerant patients), improper dosing, and/or improper product selection." (warning letter 1).

According to Jeffrey M. Dayno, M.D., vice-president of medical services at Cephalon, manufacturer of Fentora, the drug is indicated only for the management of breakthrough pain in patients with cancer in persistent pain who are already receiving and who are tolerant to opioid therapy and SHOULD NOT be used in opioid non-tolerant patients

Breakthrough pain (BTP) is pain that arises suddenly, unforeseen, for short periods of time, and is not alleviated by the patients' normal pain suppression management. The Breakthrough pain may appear in cancer patients. Breakthrough pain characteristics may vary from person to person, including the duration and possible causes. If you are interested in learning more about pain or BTP you may go to The American Chronic Pain Association web site (http://www.theacpa.org) or a Breakthrough Pain Web site (http://www.breakthroughpain.com/)

Additional key safety indications are spelled out in the warning letters including:

* Use FENTORA should be used only for labeled indications
* FENTORA should not be prescribed for patients with acute pain, postoperative pain, headache, migraine, or sports injuries
* FENTORA is not a generic version of Actiq. Therefore, should not be used as a substitute for Actiq or other fentanyl-containing products
* Dosing instructions should be followed carefully
* Follow dosing instructions carefully:
a) For unrelieved breakthrough pain (BTP), patients should NOT take more than 2 FENTORA tablets per BTP episode
b) Patients MUST wait at least 4 hours before treating another BTP episode with FENTORA

What is Fentora?

FENTORA contains fentanyl, an opioid agonist and a Schedule I1 controlled substance, with an abuse liability similar to other opioid analgesics. FENTORA can be abused in a manner similar to other opioid agonists, legal or illicit. This should be considered when prescribing or dispensing FENTORA in situations where the physician or pharmacist is concerned about an increased risk of misuse, abuse or diversion. Schedule I1 opioid substances which include morphine, oxycodone, hydromorphone, oxymorphone, and methadone have the highest potential for abuse and risk of fatal overdose due to respiratory depression.

Sources:

Important Safety Information for FENTORA for Doctors. Warning Letter. FDA. URL: http://www.fda.gov/medwatch/safety/2007/fentora_deardoc_%20Letter_09-10-07.pdf

Important Safety Information for FENTORA for Health Care Professionals. FDA. URL: http://www.fda.gov/medwatch/safety/2007/Fentora_DearHCP_Letter%2009-10-07.pdf