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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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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