Consumption of calcium antagonists: results of the German national health surveys.

Purpose: In generating firm conclusions concerning the efficacy and safety of drugs, the description of the exposed population should be one of the first steps in pharmacoepidemiological studies. The present investigation describes the frequency of usage and calcium antagonists in relation to sociodemographic data and parameters of morbidity statistics. Additionally statements are made concerning co-medication, drug tolerability and side-effects.

Statutory regulations governing the reporting of adverse reactions.

Under the Drug Law (AMG) of 1976, applicants for marketing authorisations were obliged to notify the competent authorities of any new information about the product.When the Second Amendment came into force on 17 February 1987, the regulation became tighter in so far as applicants were obliged to notify the competent authority once they get to know of any suspected adverse reaction or interaction with other agents that could be a health hazard, including frequent drug abuse or a considerable drug abuse in an individual case.