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Senior Citizen Alerts
Fentora Cancer Pain Drug Draws FDA Warning of
Potential Serious Side Effects
Concern due to reports of deaths, other adverse
events from fentanyl buccal
 Sept. 26, 2007 - The Food and Drug Administration
is alerting health care professionals and consumers to concerns over the
use of Fentora (fentanyl buccal) tablets after recent reports of deaths
and other adverse events.
Fentora, a potent opioid pain medication, is used
only for treatment of breakthrough pain in cancer patients receiving
opioid treatment and who have become tolerant to it.
Breakthrough pain
is intense increases in pain that occur with rapid onset, even when opioid pain-control medication is being used. Patients who take narcotic
pain medications daily and around-the-clock develop tolerance and are
more resistant to the dangerous side effects of these medications than
patients who take narcotic pain medication on a less frequent basis.
The deaths reported were the result of improper
selection of patients, dosing, or improper product substitution.
"FDA is monitoring this issue very closely," said
Steven Galson, M.D., M.P.H., director of FDAs Center for Drug
Evaluation and Research. "We are working with the manufacturer to ensure
the safest use of this medicine. Health care professionals and patients
need to be aware of the potential for fatal overdose with the improper
use of Fentora."
In its Public Health Advisory and Health Care
Professional Sheet published today, FDA warned physicians and other
health care professionals that it is critical to follow product labeling
when administering Fentora.
FDA further stated that it is dangerous to
use Fentora for any short-term pain such as headaches or migraines. It
is critical that Fentora not be used in patients who are not opioid
tolerant.
Patients also must be under a doctors care and
close supervision while taking Fentora and the dose should be carefully
adjusted to control breakthrough pain adequately.
In addition, FDA is concerned about the improper
substitution of Fentora, a quick acting pain drug, for other pain
medicines. Fentora is not the same as other fentanyl products and cannot
be substituted for Actiq, another fentanyl product used to treat
breakthrough cancer pain. Because Fentora delivers more fentanyl to the
blood than Actiq, substituting Fentora for Actiq using the same dose can
result in a fatal overdose.
On Sept.10, 2007, Cephalon Inc., the manufacturer
of Fentora, sent letters to physicians and other health care providers
advising them about the adverse events and deaths reported for Fentora.
FDA is reviewing available information including adverse events. The
agency has asked the company to strengthen warnings and improve the
dosing instructions in the drugs product labeling. FDA also requested
that the company improve their education plan for prescribers and
pharmacists on the proper patient selection, dosing instructions and
restrictions on substituting Fentora for other products.
Adverse events related to this product should be
reported to MedWatch, the FDAs voluntary reporting program:
www.fda.gov/medwatch/report.htm
800-332-1088
Fax: 800-332-0178
Mail: MedWatch, Food and Drug Administration, 5600 Fishers Lane,
Rockville, MD 20852-9787
For more information, please visit:
Fentanyl Buccal Tablets (marketed as Fentora)
More, too, at company site -
http://www.fentora.com/
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