[Spontaneous reports on unwanted drug effects in the years 1978-1979]

In 1978/1979 the Medicines Commission of the German Medical Profession received 5196 spontaneous reports on adverse drug reaction (ADRs) from physicians, manufacturers, intensive hospital monitoring and pharmacists. The total number of ADRs reported by the physicians was 1867. The symptoms mostly seen were skin reactions, blood dyscrasia, drug dependence, liver damage (including jaundice), nausea, vomiting and hyper-or hypotension. Drug dependence was reported more frequently than was the case in the years before due to a large number of reports dealing with only one anorectic drug. The drugs most frequently associated with ADR reports were analgesics, psychotropic agents, antiarrhythmic agents, agents used against gastrointestinal disorders, sedatives and hypnotics, antibiotics and radioopaque media. The frequency of drugs involved roughly corresponded to the sales figures in 1979 with radioopaque media over-represented and some groups not or under-represented (e.g. vitamins, antitussives and vasoprotective agents). The spontaneous reporting system does not provide absolute figures on the frequency of ADRs. Its main purpose is to draw the attention of the physicians to an increase in the rate of ADRs for a certain drug or to rare but extremely severe incidences.