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Re: FDA delay for new antidepressant

Posted by 8 Miles on December 6, 2003, at 17:50:38

In reply to FDA delay for new antidepressant « Robert Fairburn, posted by Dr. Bob on November 26, 2003, at 21:37:19

Actually, your theory that "the rest of the world" won't have access to meds may not actually be the case. If you will check, you will find that many meds have been used in Europe and elsewhere (even made by U.S. companies) for many years that are not yet available HERE. Maybe that's the way the med companies can gather data to present to the FDA that a drug does not have any terrible side effects, and is effective in treating the condition for which it was developed.
Then, of course, there are meds like Wellbutrin that were actually produced in the 1970's that were prescribed at the wrong dosage, which caused a lot of problems (seizures in this case) so they were taken away. Only years later did Wellbutrin come back out with dose reduction, and warnings about decreasing one's seizure threshold. We will have to see how this plays out, but the bottom line is profit for the companies, and safety and efficacy for the FDA.

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poster:8 Miles thread:284305
URL: http://www.dr-bob.org/babble/social/20031124/msgs/287233.html