Comments on: FDA Issues Warning About Botox Deaths http://www.pharmalot.com/2008/02/fda-issues-warning-about-botox-deaths/ News, Comment and Conversation Fri, 10 Feb 2012 18:49:54 +0000 http://wordpress.org/?v=2.6.2 By: research literature | Hot Trends http://www.pharmalot.com/2008/02/fda-issues-warning-about-botox-deaths/#comment-148065 research literature | Hot Trends Sat, 09 Feb 2008 20:05:48 +0000 http://www.pharmalot.com/2008/02/fda-issues-warning-about-botox-deaths/#comment-148065 [...] FDA Issues Warning About Botox Deaths [...] [...] FDA Issues Warning About Botox Deaths [...]

]]> By: Chris http://www.pharmalot.com/2008/02/fda-issues-warning-about-botox-deaths/#comment-147054 Chris Sat, 09 Feb 2008 01:40:20 +0000 http://www.pharmalot.com/2008/02/fda-issues-warning-about-botox-deaths/#comment-147054 We've had similar discussions on here before which always go back to the inability of any regulatory agency to forecast events that are not suggested by available clinical data used in submissions. The massive increase in usage of cosmetic Botox in approved indications raised the likelihood of side effects, although I'm not sure that there was an increase in incidence. And how many 'patients' received more shots than the approved schedule is unknown, so again, FDA can't predict that. And when chilren with cerebral palsy are treated off label (because their doctors felt it worthwhile) it's entirely the decision of the physician and family. Just saying that it's easy to slam the FDA - as any other reg authority - but I guess it's hard to be perfect all the time. The key thing I suppose is to be aware and react when things turn sour; perhaps that's how they should be judged. NB Sidney Wolfe. We’ve had similar discussions on here before which always go back to the inability of any regulatory agency to forecast events that are not suggested by available clinical data used in submissions. The massive increase in usage of cosmetic Botox in approved indications raised the likelihood of side effects, although I’m not sure that there was an increase in incidence. And how many ‘patients’ received more shots than the approved schedule is unknown, so again, FDA can’t predict that. And when chilren with cerebral palsy are treated off label (because their doctors felt it worthwhile) it’s entirely the decision of the physician and family. Just saying that it’s easy to slam the FDA - as any other reg authority - but I guess it’s hard to be perfect all the time. The key thing I suppose is to be aware and react when things turn sour; perhaps that’s how they should be judged. NB Sidney Wolfe.

]]> By: Matt http://www.pharmalot.com/2008/02/fda-issues-warning-about-botox-deaths/#comment-147038 Matt Sat, 09 Feb 2008 01:15:25 +0000 http://www.pharmalot.com/2008/02/fda-issues-warning-about-botox-deaths/#comment-147038 Is the FDA even capable of protecting Americans from drugs that cause serious harm? Seems like tons of drugs get FDA approval and then years later the FDA acknowledges side effects such as suicidal ideation, death, diabetis, etc... Is the FDA even capable of protecting Americans from drugs that cause serious harm?

Seems like tons of drugs get FDA approval and then years later the FDA acknowledges side effects such as suicidal ideation, death, diabetis, etc…

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