Abstract: The prescription records of 1948 Dutch women who delivered a live-born infant during an 18 month period in 1987 and 1988 were set against the Australian classification of drugs with respect to the known or suspected risks in pregnancy. During pregnancy the use of drugs with proven or anticipated foetal toxicity proves to decrease, indicating that the medical profession is relatively well aware of these potential side effects. In the case of antibiotics the fall in the use of potentially toxic drugs is due to a shift to relatively less toxic drugs whereas the decreased use of analgesics and some…antirheumatic drugs is not accompanied by replacement by others. Prescriptions for hormonal contraceptives were sometimes actually filled in the first trimester of pregnancy, and the figures suggest that exposure to these products in early pregnancy may not be negligible. The present study shows that in spite of the generally favourable trends, 167.8 out of 1000 women received during the course of pregnancy one or more prescriptions from the higher risk categories (D, C or B3) in the Australian system. By combining such utilization studies with data from registries of birth defects one will be able to develop the fund of knowledge and to ensure that the classification of drugs with respect to their risks in pregnancy is as accurate as it can reasonably be.
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Keywords: Drug utilization, Teratogenicity, Risk classification system, Pregnancy, Prenatal care
Abstract: This study describes the use of the ovulation stimulating drugs clomifene, human chorionic gonadotropin (hCG) and human menopausal gonadotropin (hMG) in a representative sample of a population of Dutch women in the child-bearing age group. Clomifene or hMG/hCG are seldom used alone. A considerable percentage of the women received at least four different ovulation-inducing and related drugs during the observation period of two years. Thirty percent of the women who used clomifene were treated for 6 or more cycles. These findings argue for a relative “overuse” and “misuse” of clomifene. Buserelin, a drug not registered for the indication ovulation induction…in The Netherlands but used in in vitro fertilization (IVF) programs as inhibitors of pituitary gonadotropin production, was nevertheless prescribed to 38% of the hMG /hCG users and to 11 % of the clomifene users. Our study indicates that, though the potential risks of congenital malformations due to clomifene are difficult to assess, they may be considerable; this, and the fact that different ovulation-inducing drugs are used together with clomifene, emphasizes the need for post-marketing surveillance.
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Keywords: Clomifene, Human chorionic gonadotropin (hCG), Human menopausal gonadotropin (hMG), Drug utilization, Pharmacy records