Fentora Linked to Patient Deaths

Kim Dixon with Reuters reported today, Thursday September 13 that Cephalon Inc. (NasdaqGS:CEPH - News) has warned doctors about deaths that have been linked to its Fentora pain drug for cancer patients.

According to the The U.S. Food and Drug Administration (FDA), Cephalon issued two Dear Healthcare Professional Letters to inform prescribers and other healthcare providers of important safety information regarding Fentora.

Fentora is indicated only for the management of breakthrough pain in patients with cancer who are already receiving and who are tolerant to opioid therapy for their underlying persistent cancer pain.

Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/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.

[September 10. 2007 - Dear Doctor Letter - Cephalon]
[September 10, 2007 - Dear Healthcare Professional Letter - Cephalon]
[March 2007 - Label with Medication Guide - Cephalon]

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