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FENTORA
Cephalon, the makers of Fentora, has issued two "Dear Healthcare Professional" letters to inform users and healthcare providers of important safety information regarding Fentora. Fentora is used for the management of breakthrough pain in patients with cancer. Serious adverse events, including deaths, have occurred in patients treated with Fentora. Cephalon said Fentora has been linked to a total of four deaths.
The deaths may have occurred as a result of improper patient selection, improper dosing, or improper product substitution. The healthcare professional letters provide key points regarding appropriate patient selection and proper dosing and administration of Fentora to reduce the risk of respiratory depression.
Fentora has been approved by the Food and Drug Administration only for use in cancer patients, but they are often prescribed "off-label" for such ailments as headaches and back pain. Fentora contains fentanyl, a highly addictive substance - 80 times as potent as morphine. Fentanyl is classified as a Schedule II substance by the Drug Enforcement Administration, which puts it in the same category as cocaine and methamphetamine. Schedule II drugs have the highest potential for abuse and an associated risk of fatal overdose.
Fentora was approved by the FDA on September 25th, 2006. Since then, more than 78,000 prescriptions were written for the drug. Fentora is a faster-acting pain reliever than Actiq, which is a lozenge on a stick that looks like a lollipop. Actiq has been associated with more than 120 deaths.
FENTORA NEWS
Deaths prompt FDA to issue alert to health care professionals regarding the use of the opioid pain medication Fentora. (Oct-01-07) AAFP: FENTORA
US drug regulators have issued a public health advisory warning of the potential for deadly overdose of the pain drug Fentora, used for cancer patients. (SEP-26-07) REUTERS: FENTORA
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