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 [1] 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 [2], the FDA approved a Watson Pharmaceuticals version of the fentanyl pain patch.
- read the report [3] from The Los Angeles Times
Related Articles:
FDA approves Watson's pain patch. Report [4]
FDA issues warning for Ortho Evra patch. Report [1]
Government probing link between pain patch and 120 deaths. Report [5]
Links:
[1] http://www.fiercebiotech.com/story/fda-issues-warning-for-ortho-evra-patch/2005-11-11
[2] http://www.fiercebiotech.com/story/fda-approves-new-generic-pain-patch/2006-08-08
[3] http://www.latimes.com/news/science/la-na-patches27aug27,1,1522391.story
[4] http://www.fiercepharma.com/story/fda-approves-watsons-pain-patch/2007-08-21
[5] http://www.fiercebiotech.com/story/government-probing-link-between-pain-patch-and-120-deaths/2005-07-18