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


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By Rafael B.
http://www.associatedcontent.com/article/379683/fda_warning_cancer_pai
n_medication.html

According to two warning letters (warning letter 1
http://www.fda.gov/medwatch/safety/2007/Fentora_DearHCP_Letter%2009-10
- -07.pdf, warning letter 2
http://www.fda.gov/medwatch/safety/2007/fentora_deardoc_%20Letter_09-1
0-07.pdf), 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_09-1
0-07.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

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