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There are no adequate data from postmarketing surveillance on the developmental risk associated with use of BOTOX administration in pregnant women. Studies in animals have shown reproductive toxicity. The potential risk for humans is unknown. BOTOX should not be used during pregnancy unless clearly necessary. If this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential risks, including abortion or fetal malformations, which have been observed in rabbits.
It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when BOTOX is administered to a nursing woman.
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