4 Deaths Linked to Improper Use of Painkiller

Drug Manufacturer Links 4 Deaths to Improper Use of Painkiller
Thursday, September 13, 2007 14:38 PDT

WASHINGTON, D.C. -- The deaths of 2 patients prescribed a powerful
painkiller as a headache treatment were among 4 fatalities linked to the
recently approved drug, its manufacturer reported Thursday.

All 4 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 2006 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 2 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 1-for-1 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, Pennsylvania-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 2006, Steele said.