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Re: clinical trials/kicked out

Posted by Mashogr8 on February 5, 2003, at 15:20:57

In reply to Re: clinical trials, posted by LA on February 5, 2003, at 9:17:26

I was in a very early trial of paroxetene to determine the efficacy and safety of its longterm use. After I had been on the drug with increased dosages and close to a year on the drug (maybe it was only six months, can't remember) it was time to do follow up studies, blood work, a physical and a chest x-ray. All the results were fine except the chest xray. It showed a shadow of sorts which twas identified as sarcoidosis following an inconclusive bronchoscopy and then a mediastinoscopy. The drug company paid for all medical expenses since there was no way of proving that the paroxetene caused/did not cause the problem. The bottom line was I was "kicked out" of the study even though my depression was greatly relieved for the first time since taking all sorts of medication combinations.

The drug companies need to find out whether there are unknown or unexpected side effects. For me, it seems that since I was no longer involved the sarcoid episode could be ignored. And there was no attempt by the drug company to find another medication alternative and no way they would let me continue receiving paroxetene (it was not on the market yet).

MA


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