fentanyl

New warning for off-label Fentora

Thu, 27 Sep 2007 06:59:56 -0400

The FDA issued a warning yesterday on Fentora, the Cephalon painkiller recently linked to three deaths. 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
- read the article from the Philadelphia Inquirer

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Cephalon takes heat for off-label narcotic promotion. Report

Red flags raised on Fentora misuse

Fri, 14 Sep 2007 06:59:58 -0400

Pain can be a killer. Cephalon officially warned doctors yesterday to use its opioid pain reliever Fentora very, very carefully, or patients might die. Some already have, while others have experienced severe side effects--but only because of improper dosing or substitutions, or because they should never have been given opioids in the first place.

Cephalon said Fentora should only be used for cancer patients already using other opioids like morphine or another fentanyl product--not for post-op pain, migraines, sports-injury pain, and the like. And Fentora isn't a substitute for other fentanyl products. Investors reacted quickly to the news, sending shares down by more than 4 percent in double its usual daily trading volume.

- check out this release
- here's the report from SmartMoney

Related Articles:
FDA approves Fentora for cancer pain. Report
Cephalon shares jump on Fentora decision. Report
Cephalon takes heat for off-label narcotic promotion. Report

Patch delivers killer doses

Mon, 27 Aug 2007 06:59:58 -0400

Dear FDA: Sometimes warnings don't get through--just witness the Surgeon General's stamp on cigarette packages. Or, closer to home, consider the cautionary language slapped onto painkiller patches.

According to an LA Times investigation, the fentanyl patches are still killing patients, despite the FDA's guidance that patches shouldn't be used for post-op treatment and should only be administered "with great caution." The newspaper raises the spectre of similar dose-related problems with delivering other drugs via patch, especially now that new technology promises to put patches to wider use.

The Ortho Evra contraceptive patch, for example, came under FDA fire because it exposes women to higher doses of a hormone linked to dangerous blood clots; recently, a doctors' group in Tennessee decided to stop prescribing it altogether, contributing to a 18-month plunge in sales of the Ortho-McNeil drug. Meanwhile, drug makers soldier on: Just last week, the FDA approved a Watson Pharmaceuticals version of the fentanyl pain patch.

- read the report from The Los Angeles Times

Related Articles:
FDA approves Watson's pain patch. Report
FDA issues warning for Ortho Evra patch. Report
Government probing link between pain patch and 120 deaths. Report