The Problem Of Informative Package Leaflets For Hormonal Substitute Preparations

The package leaflets of hormone preparations used for Hormone Replacement Therapy (HRT) in hypoestrogenaemic women contain contraindications, which are taken from the package insert of oral contraceptives: Clots in the blood vessels (thrombotic disorders), high blood fats, severe diabetes, abnormal red blood cells, deterioration of inherited deafness and jaundice not explained by infections, disturbances of the Liver function and of existing or treated hormone-dependent tumours of the breast or of the lining of the womb. Numerous epidemiologic, animal-experimental and also clinical studies proved that the cardiovascular risk, hepatic discomfort and the influence on the blood system of oestradiol 17-beta have to be evaluated completely differently compared to the ethinyloestradiol used in oral contraceptives; therefore, many of the listed contraindications must be reconsidered. In our review we try to emphasise this postulation by scrutinising recent publications.