Abstract. Iron absorption, bone‐marrow smears and haematological parameters were repeatedly studied during pregnancy in 50 women. The same studies were repeated two months after delivery. The material was randomly divided into two groups. Twenty‐four women were treated with 200 mg of ferrous iron daily while 26 were given placebo. The iron absorption was measured from radioiron‐labelled test doses of 100 mg ferrous iron in a whole‐body counter with high sensitivity.In the placebo group the iron absorption increased throughout pregnancy from an average of 6.5 % at the 12th week to 14.3 % at the 35th week of gestation. Two months after delivery the absorption was higher than initially. In the iron‐treated group the absorption increased between the 24th and 35th week of gestation from 6.0 to 8.6 %. After delivery 5.5 % of the test dose was absorbed.The haemosiderin iron in the bone‐marrow was mobilized during pregnancy. In the placebo group no woman had more than trace of haemosiderin in the bone‐marrow smears at the 35th week of gestation. In the iron‐treated group 65 % had the same bone‐marrow findings. The amount of bone‐marrow haemosiderin at term seems not to have the same significance for the diagnosis of iron deficiency in pregnancy as in non‐pregnant subjects. Two months after delivery about 50 % of the women in the placebo group had restored their iron depots. In the iron‐group the haemosiderin content in the bone‐marrow smears was enhanced in most women compared to early pregnancy. In the placebo group haematoLogical data indicated a high frequency of iron deficiency in late pregnancy while in the iron‐treated group iron deficiency was prevented.
SUMMARY
Using a double‐blind and placebo technics, the side‐effects of tablets containing different iron compounds were compared in 1496 subjects. Three separate series, all of which included placebo and ferrous sulphate tablets were studied. The agreement between the results obtained in different series was very good.
Ferrous sulphate, ferrous gluconate, ferrous fumarate, and ferrous glycine sulphate had almost the same incidence and type of side‐effects. The incidence was significantly higher than when placebo tablets were given.
This review comprises data from more than 19,000 individuals who have taken part in clinical studies of omeprazole. Isolated, non-specific adverse events which might be attributable to omeprazole have included nausea, dizziness, headache and diarrhoea. These events have been generally mild and transient and have not usually required either a reduction of dose or cessation of therapy. The frequency and spectrum of adverse events have been the same in those over 65 years of age as in younger patients. No drug-related adverse events have been found in patients with renal insufficiency or severe liver failure. More than 1.2 million patient treatments of omeprazole have now been given. The overall incidence of adverse events with omeprazole is low, and in comparative studies has been in the same range as that found with H2-receptor antagonists. Importantly, no dose-related adverse events have been observed with omeprazole in the dose range 10–60 mg/day. Furthermore, none of the serious adverse events that have been reported have been attributable to omeprazole. No histological changes in oxyntic endocrine cells have been found after short-term periods of treatment with either omeprazole or H2-receptor antagonists in patients with peptic ulcer disease. Long-term continuous high-dose omeprazole treatment of patients with Zollinger-Ellison syndrome has not induced any significant increase in the oxyntic endocrine cell hyperplasia. Investigations of the gastric mucosa from patients in a compassionate use programme who have received omeprazole, usually 20 mg daily, for periods of up to 37 months, have been performed. Two hundred and forty-eight patients had their last biopsy taken after at least 11 months of treatment. No drug-related changes in gastric endocrine cells were found. Clinically serious changes in laboratory variables have been uncommon, and an extensive evaluation of different laboratory variables has not revealed any clinically significant changes during omeprazole treatment. Thus, the clinical safety of omeprazole has been found to be favourable.
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