International drug information notes: the risks of calcium channel blockers

ABSTRACT

Publication of two epidemiological studies [1.2] and a meta-analysis [3] demonstrating an association between calcium channel blockers and an increased risk of myocardial infarction [MI] and excess mortality raised a contentious debate about the safety of these drugs in the united states. Central to the debate were the validity of epidemiological research in showing an association between calcium channel blockers and harm and a formal request made to the U.S. food and drug administration [FDA] to add a warning label to all calcium channel blockers marketed in the U.S. reflecting the finding of these three studies. Below is an edited version of the letter written to FDA commissioner David A. Kessler M.D.J.D. on November 9, 1995 requesting a warning be added to the official product labeling of all calcium channel blockers marketed in the U.S.