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Although no teratogenic effects were seen in animal testing with doxazosin, reduced fetal survival was observed in animals at extremely high doses. These doses were approximately 300 times the maximum human recommended dose.
A single case report demonstrated transfer of doxazosin into human breast milk and animal studies have shown that doxazosin accumulates in breast milk (see Pharmacology: Toxicology: Preclinical safety data under Actions).
As there are no adequate and well-controlled studies in pregnant or nursing women, the safety of doxazosin/doxazosin GITS during pregnancy or lactation has not yet been established. Accordingly, during pregnancy or lactation, doxazosin/doxazosin GITS should be used only when, in the opinion of the physician, the potential benefit outweighs the potential risk.
