Deaths Blamed on Improper Painkiller Use
Narcotic Painkiller Looks, Tastes Like Lollipop; Abuse A Concern
From Associated
Press (From Google)
By The Associated Press
September 13, 2007
WASHINGTON (AP) — The deaths of two patients
prescribed a powerful painkiller as a headache treatment were among four
fatalities linked to the recently approved drug, its manufacturer reported
Thursday.
All four deaths apparently involved improper use of the drug, called Fentora,
manufacturer Cephalon Inc. said. The Food and Drug Administration was monitoring
the situation, a spokeswoman said.
The FDA approved the drug in September for use only by cancer patients already
taking morphine or other prescription narcotics for their pain. Fentora contains
fentanyl, which is similar to morphine, but far more potent.
Besides the two headache patients, the other deaths involved a suicide and
a patient administered the drug outside the recommended dosing.
"None of the reports were in cancer patients, which leads us to believe
they were inappropriate candidates for the product," Cephalon spokeswoman
Candace Steele said.
Cephalon reminded doctors and pharmacists, in letters dated Monday but released
Thursday by the FDA, of who should take the drug, and in what quantities
and how often. The company also warned not to substitute Fentora on a one-for-one
basis for another, older fentanyl drug called Actiq that it also makes, because
the newer drug is stronger.
"The FDA takes this very seriously, and is working with the company
to assure the safest possible use of this medication," agency spokeswoman
Susan Cruzan said.
Steele said the deaths were not linked to allegations
subject to investigation that Cephalon engaged in improper promotion of
Fentora and other drugs for uses other than those outlined in their FDA-approved
labels. While it's not illegal for doctors to prescribe drugs for so-called "off-label" uses,
companies are prohibited from marketing medicines for those purposes.
Last month, Frazer, Pa.-based Cephalon said it was cooperating with the
investigations by Congress, the U.S. attorney's office in Philadelphia and
Connecticut attorney general.
Doctors have written about 78,000 prescriptions for Fentora tablets since
October, Steele said.
<< BACK
TO DANGEROUS DRUG NEWS ARCHIVE