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Re: File drug complaints with FDA Medwatch

Posted by OldSchool on January 24, 2002, at 21:14:53

In reply to Re: The musical meds - incidence report » medlib, posted by Chris A. on January 23, 2002, at 1:37:07

> Tried to start a new thread, but my computer says "no."
>
> What's the procedure for filing an incidence report with a pharmaceutical company? Is it worth the effort to left them know of adverse events? I also had a lot of hopes for Geodon, but the akathisia dashed those.
> Do you know anything about filing incidence reports with the makers of ECT machines? Do they just get trashed?
>
> I don't have a legal bone in my body, but somehow feel someone needs to know that adverse events affect real people.
> Perhaps better meds and better treatments will emerge if we speak up. Dream on.
>
> Thanks,
>
> Chris A.
>
> P.S. Good to see you posting, Scott
>
> > I have to go fill out the incidence report Pfizer sent. (And it's been only 2 months since they received my complete report and inquiry! Guess it's a good thing I wasn't holding my breath waiting for assistance from *that* source.) Geodon didn't work for you either? I wonder how it's doing with schizophrenics; it hasn't exactly reached warp speed with Babblers, from what I've read so far.

Reporting "adverse events" to the drug company that made the drug is a waste of time. You wont get anywhere doing that. The place to report adverse drug events is something called "FDA Medwatch." Medwatch is specifically set up as a centralized complaint department with the FDA. Upon request the FDA will send you Medwatch forms to fill out and return. The form you want is Medwatch Form 3500. You can have your doctor who prescribed the drug assist you in filling out the form if you wish. Or in many cases you might not be able to get your doctor to admit the drug caused you a problem and will refuse to help you fill it out. In which case you fill it out yourself and send it in.

The website for FDA Medwatch is:

http://www.fda.gov/medwatch/

I am getting ready to file a Medwatch complaint against Seroquel for causing me EPS back in the fall.

Old School


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