It took many decades before the deleterious effects of aspirin on the gastro-intestinal tract became apparent and almost as long before it was recognised that the protracted abuse of phenacetin could produce renal papillary necrosis; 35 years elapsed before it became clear that amydopyrine could cause agranulocytosis; and several years before the association of phocomelia with thalidomide became obvious⁸.

Withdrawals from the market as a result of spontaneous reporting

After the “thalidomide tragedy” many countries have established drug monitoring systems for early detection and prevention of possible drug-related morbidity and mortality. Their success depends on the cooperation of the medical profession in reporting suspected ADRs, especially to new drugs.

Some examples demonstrate how very astute, alert and observant medical doctors have been helped to prevent the development of drug morbidity and drug mortality by reporting on suspected ADRs which resulted in the withdrawal of dangerous drugs from the market or in restriction of their use.