In this study the need for information about drugs among pregnant women and the use of available sources was explored. The women participating in this study were well aware of the risks of the use of drugs. Health professionals were considered to be important sources of information and they should therefore use up-to-date information concerning this topic. Health professionals should also bear in mind in their counseling activities that the beliefs of pregnant women on the safety and need of drugs might lead to reasoned non-compliance.
Etretinate has been detected in the blood of women taking acitretine. Because of the proven teratogenic effects of etretinate it was decided to try to trace all users of acitretine in The Netherlands via all drug dispensing outlets (1450 community pharmacies, 95 hospital pharmacies and 636 general practitioners). A request for information on the date of birth, sex, type of prescriber, and the number of capsules dispensed yielded a response rate of 87%. In 61% of all the responding dispensing outlets a prescription for acitretine had been filled. Of these 1153 outlets, 40% had dispensed acitretine to one patient and 52% had dispensed it to 2-5 patients. The 2717 patients comprised 1500 men (55%) and 1217 women, with mean ages of 48 and 53 y, respectively. As against 45% of all the male users, 31% of all the women were in the child-bearing age (15-45 y). The average numbers of dispensed capsules was 167 to users of 10 mg capsules, and 107 to users of the 25 mg capsules. In more than 80% of cases acitretine had been prescribed by dermatologists. Because the large majority of inhabitants in The Netherlands use one community pharmacy, and because most of them have automated records, it is possible to trace a cohort of users quickly and almost completely. Because most large-scale problems with adverse reactions are discovered within the first 2 years of marketing, at a time when exposure and morbidity registries are still collecting information, ad hoc formation of a cohort in this way may be a useful resource for postmarketing surveillance.
1. The effects of indomethacin on water excretion during both vasopressin stimulation and inhibition were studied in control subjects and in patients with sickle cell anaemia.2. In the control group as well as in the group of patients with sickle cell anaemia sodium and urea retention occurred after indomethacin in the water-depleted state. During water loading, indomethacin induced sodium retention without urea reabsorption.3. In healthy volunteers indomethacin increased urinary osmolality during water deprivation, but not after water loading. In contrast, in patients with sickle cell anaemia indomethacin caused a rise in urinary osmolality during water loading, but not after water deprivation.4. The findings support the view that indomethacin promotes solute reabsorption in the distal tubule. 5.From our observations we conclude that renal prostaglandins are not involved in the urinary concentrating defect of patients with sickle cell anaemia. On the other hand, the normal diluting capacity in sickle cell anaemia appears to depend on renal prostaglandins.
If a drug treatment is not really needed, at what point are the risks of adverse effects considered too high? This is the central question behind Herings and Stricker's study of cardiovascular adverse effects and the use of bromocriptine for lactation suppression [I].Bromocriptine mesylate, a dopamine receptor agonist, is a semisynthetic ergot derivate. High doses (30-75 mg daily) are used for parkinsonism; low doses (2.5-5.0 mg daily) are used for prostatic tumours and for suppression of physiological lactation. Bromocriptine is used also in the treatment of prolactin-secreting adenomas, hyperprolactinaemiarelated conditions such as galactorrhoea, menstrual disorders and infertility, and for growth hormone suppression.Lactation is a self-limiting condition -the ability to lactate disappears rapidly if a woman is not breastfeeding. Discomfort occurs between 2-7 days after delivery but engorgement usually disappears in I to 2 days. A review of a number of studies concluded that the majority of women can be adequately treated with conservative, non-pharmacological aids such as a tight brassiere, avoidance of nipple stimulation and the use of cold packs, with or without minor analgesics.The indication "prevention of postpartum breast engorgement" was introduced for bromocriptine in about 1980 in the United States as well as in many other countries worldwide. Bromocriptine has been widely used for the prevention of physiological lactation. Sandoz estimated in October 1994 that 23 million women worldwide had used Parlodel | and Pravidel | its brands of bromocriptine, for lactation suppression [Lexchin J, personal communication]. Bromocriptine is effective in preventing lactation and postpartum breast engorgement only if prescribed before lactation begins. It is generally prescribed for 2 weeks, but many women need to take the drug for a third week because they experience rebound lactation after discontinuation of the drug. Adverse effects such as headache, nausea, dizziness, vomiting and rash were experienced by 5 to 20 per cent of women prescribed bromocriptine to suppress lactation in clinical trials. The most important adverse experience was hypotension, which was dose-and time-related. At the time of approval, there were no reports of hypertensive crises, seizures or cerebrovascular accidents.
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