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Pregnancy: There are no adequate data from the use of methylthioninium chloride in pregnant women. Studies in animals have shown reproductive toxicity (see Pharmacology: Toxicology: Preclinical Safety Data under Actions). The potential risk for humans is unknown. Proveblue should not be used during pregnancy unless clearly necessary, e.g. in lifethreatening methaemoglobinaemia.
Breast-feeding: It is unknown whether methylthioninium chloride is excreted in human breast milk. The excretion of methylthioninium chloride in milk has not been studied in animals. A risk to the suckling child cannot be excluded. Based on kinetic data, breast-feeding should be discontinued for up to 8 days after treatment with Proveblue.
Fertility: In vitro, methylthioninium chloride has been shown to reduce motility of human sperm in a dose dependent manner.
