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In clinical studies on Aldactazide and pregnancy, spironolactone (one of the components of the medication) caused miscarriages and problems in reproductive systems of fetuses when it was given to pregnant rabbits and rats. Also, diuretics should generally be used in pregnant women only when absolutely necessary. Due to these possible risks, notify your healthcare provider immediately if you are taking Aldactazide and pregnancy occurs.
For women who are pregnant, Aldactazide® (spironolactone-HCTZ) may not be safe. This is based on animal studies that looked at the effects of the drug during pregnancy.
The U.S. Food and Drug Administration (FDA) uses a category system to classify the possible risks to a fetus when a specific medicine is taken during pregnancy. Pregnancy Category C is given to medicines that have not been studied in pregnant humans but that do appear to cause harm to the fetus in animal studies. Also, medicines that have not been studied in any pregnant women or animals are automatically given a pregnancy Category C rating.
When given to pregnant rabbits, spironolactone (one of the components of Aldactazide) caused an increased risk of miscarriages. When given to pregnant rats, spironolactone caused problems in reproductive systems of the fetal rats (especially males). Spironolactone can decrease or block male hormones, which are necessary for the development of male fetuses.
However, it is important to note that animals do not always respond to medicines the same way that humans do. Therefore, a pregnancy Category C medicine may be given to a pregnant woman if her healthcare provider believes that the benefits to the woman outweigh any possible risks to the unborn child.
Generally, diuretics (including Aldactazide) should be used in pregnant women only when absolutely necessary. Aldactazide should not be used to treat high blood pressure during pregnancy.