The FDA issued a warning yesterday on Fentora, the Cephalon painkiller recently linked to three deaths [1]. All three stemmed from off-label use of the fentanyl drug, which is approved only for treatment of breakthrough cancer pain.
Cephalon had warned doctors two weeks ago of the risk of fatal overdose with Fentora. But the company may have played a role in pushing off-label prescriptions. Since 2004, Cephalon has drawn scrutiny from state and federal prosecutors, and from a Congressional oversight committee, for allegedly promoting off-label uses of several drugs, including Fentora.
- see the FDA warning [2]
- read the article [3] from the Philadelphia Inquirer
Related Articles:
Red flags raised on Fentora misuse. Report [1]
FDA approves Fentora for cancer pain. Report [4]
Cephalon shares jump on Fentora decision. Report [5]
Cephalon takes heat for off-label narcotic promotion. Report [6]
Links:
[1] http://www.fiercepharma.com/story/red-flags-raised-fentora-misuse/2007-09-14
[2] http://www.fiercebiotech.com/press-releases/fda-warning-fda-warns-potential-serious-side-effects-breakthrough-cancer-pain-drug
[3] http://www.philly.com/philly/business/20070927_Warning_issued_on_Cephalon_painkiller.html
[4] http://www.fiercebiotech.com/story/fda-approves-fentora-for-cancer-pain/2006-09-26?utm_source=related&utm_medium=internal
[5] http://www.fiercebiotech.com/story/cephalon-shares-jump-on-fentora-decision/2006-06-30?utm_source=related&utm_medium=internal
[6] http://www.fiercebiotech.com/story/cephalon-takes-heat-for-off-label-narcotic-promotion/2006-11-21