Pain Pill Linked to 4 Deaths
But company says fatalities
happened due to misuse
From www.sltrib.com
By Bloomberg News
September 13, 2007
Cephalon Inc., which has a drug-making lab in Salt Lake City, warned doctors
that patients died after receiving the painkiller Fentora and that the fatalities
occurred because of improper use.
Four people died, a company spokeswoman said Thursday. The warning appeared
in a letter Monday, also citing other serious side effects, posted on the
Food and Drug Administration's Web site. The deaths occurred because patients
who can't tolerate opioid drugs were given Fentora, the medicine was improperly
substituted for other painkillers and patients received the wrong doses,
Cephalon said.
Cephalon is one of several drug companies under investigation by Congress
for allegedly promoting its drugs for uses not approved by the FDA. Doctors
are allowed to prescribe medications for any use they deem appropriate, though
companies are only allowed to market products for uses approved by the government.
A company representative said the deaths were not linked to allegations
that Cephalon improperly promoted the drug for so-called off-label use.
Fentora, a tablet, was approved a year ago only as a treatment for pain
flare-ups, called breakthrough pain, in cancer patients. Cephalon, based
in Frazer, Penn., also sells an older painkiller called Actiq, which has
generic competition. Both are a version of fentanyl, a morphine-like drug.
The letter warned doctors to limit prescriptions.
Fentora ''is not a generic version of Actiq'' and can't be substituted for
it, Cephalon wrote. Fentora shouldn't be given to patients with ''acute pain,
post-operative pain, headaches/migraine or sports injuries.''
The report ''tragically confirms concerns'' raised by investigators, Connecticut
Attorney General Richard Blumenthal said. His office and the U.S. attorney
in Philadelphia have been investigating Cephalon since 2004 to determine
whether the company illegally promoted its drugs for uses not yet authorized
by the FDA.
Cephalon shares fell $3.99, or 5.2 percent, to $72.55 Thursday in Nasdaq
Stock Market composite trading.
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