Detecting adverse reactions to drugs.

Abstract

1. Present attitudes to drug safety have been shaped largely by a series of disasters. 2. In 1937 about 107 people in the USA died of poisoning by diethylene glycol used as a vehicle for sulphanilamide which led to the requirement that all formulations must be licensed by the FDA before marketing. 3. Up to 1960 the rate of production of new drugs outstripped the ability to introduce them safely. In Germany, thalidomide, an effective sedative, had been introduced in 1956 but it was not until 1961, when an estimated 10,000 babies worldwide had been born with birth deformities, that the teratogenicity of this compound was recognized. 4. Further legislation soon followed, both reducing the number and lengthening the time required to introduce a new drug onto the market. However, problems were encountered with practolol in the 1970s and with benoxaprofen in the 1980s, the latter highlighting the need to make special provision for drug use in the elderly. 5. As to the future, more attention will be paid to the special needs of children and to the possible effects of genetic differences in metabolism.