Adverse Effects of Newly Marketed Drugs

Abstract

In this issue of the Journal, Van Thiel et al. describe effects of cimetidine that have not been reported previously in man. Their paper also provides an opportunity to consider the general problem of identifying previously unrecognized adverse effects of newly marketed drugs.New drugs are always marketed on the basis of comparatively limited information. In the United States, about 500 to 2000 patients usually receive a new drug during clinical trials, and at most only a few hundred of them are treated more than three to six months.A major objective of pre-market clinical research is the assessment . . .