Cephalon Inc has sent letters and warned doctors about deaths
linked to its Fentora pain drug for cancer patients, U.S. media
reported Friday.
According to Cephalon, there were four deaths involving two
headache patients prescribed a powerful painkiller as a headache
treatment, one suicide and a patient administered the drug outside
the recommended dosing.?
In the letter posted on the U. S. Food and Drug Administration
website, the company said it had become aware of "serious adverse
events, including deaths" in patients being treated with the drug
Fentora.??
However, the company said the deaths were the result of improper
dosing, improper product substitution as well as using the drug in
patients who can't tolerate opiods.
"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.
The company said the drug should only be used for cancer
patients already on other opiod drugs such as morphine or another
type of fentanyl product. Fentora, also a fentanyl product, is
indicated for use in treating breakthrough cancer pain.
The letter also said Fentora shouldn't be used to treat
post-operative pain, acute pain.
Fentora's label is now being updated to instruct doctors more
clearly on how to properly use the drug, which is meant for cancer
patients who are already on around-the-clock medicine for pain.
Doctors have written about 78,000 prescriptions for Fentora
tablets since October, said Cephalon.
(Agencies via Xinhuanet.com September 14, 2007)