03/03 BfArM Conducts Hearing on Hormone Replacement Therapy (HRT) - Risk-Benefit Evaluation Continued
Press release 03/2003
The Federal Institute for Drugs and Medical Devices (BfArM) at Bonn in Germany has now initiated a written hearing of pharmaceutical manufacturers of medicinal products for hormone replacement therapy (HRT). This hearing constitutes a continuation of the re-evaluation of this group of medicines as announced in September of 2002 (1). The marketing authorisation holders by now have the opportunity for comments before the BfArM decides on changes in the licensing status.
BfArM intends to subject the product informations of all medicinal products for HRT to extensive changes. On the one hand this is in order to take recent findings on the risks of HRT into account which became known during the past year, and on the other hand to implement harmonisation of the product informations for the corresponding medicinal products in Germany as discussed within the EU.
Intended measures include, among others, a restriction of the indications of these drugs. Medicinal products for HRT are mainly used for treatment of menopausal complaints and for prevention of osteoporosis. With regard to menopausal symptoms, HRT shall now only be considered if the complaints are pronounced and duration of treatment should be as short as possible. The sections "Undesirable effects" and "Precautions for use" of the patient information leaflet and expert information are to include more exact statements on nature and extent of the risks than so far as well as updated recommendations regarding precautionary measures for use of these medicines. On the basis of today's scientific state of the art, the benefit-risk ratio for the indication 'prevention of osteoporosis' appears to be unfavourable. Therefore, the BfArM is of the opinion that this indication can presumably not be maintained.
Depending on the duration of treatment, administration of medicinal products for HRT is associated with a significantly increased risk for the occurrence of breast cancer. Occurrence of some undesirable effects within the vascular system, e.g. venous thrombosis, heart attack, and stroke is increased as early as after one year of treatment. An increased risk due to some of these undesired effects had already been assumed on the basis of earlier epidemiological investigations and was now substantiated by the results of the so-called WHI Study (2). In the opinion of the BfArM and of other scientists who have commented on this study, other favourable effects of HRT (lowering the rate of colon cancer, reduction in the number of fractures) that were likewise observed in this study, are outweighed by the stated risks of the currently recommended indications.
(1) Urgent Drug Information (Arzneimittel-Schnellinformation) No. 04/02
(2) WHI Study, Journal of the American Medical Association (JAMA) 2002, 288: 321 - 333
Year of issue: 2003