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There are no adequate and well-controlled studies of botulinum toxin administration in pregnant women. Because animal reproductive studies are not always predictive of human response, NABOTA should be administered during pregnancy only if the potential benefit justifies the potential risk to the fetus. If botulinum toxin 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.
There are no adequate and well-controlled studies in pregnant women.
When pregnant mice and rats were injected intramuscularly during the period of organogenesis, the developmental NOEL (No Observed Effect Level) of other botulinum toxin was 4 U/kg. Higher doses (8 or 16 U/kg) were associated with reductions in fetal body weights and/or were decreased fetal skeletal ossification. In a range finding study in rabbits, daily injection of 0.125 U/kg/day (days 6 to 18 of gestation) and 2 U/kg/day (days 6 to 13 of gestation) produced severe maternal toxicity, abortions and/or fetal malformations. Higher doses resulted in death of the dams. The rabbit appears to be a very sensitive species to 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 botulinum toxin is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.
Administration of this product is not recommended during pregnancy or lactation.
