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Botulism antitoxin Pregnancy and Breastfeeding Warnings

Botulism antitoxin Pregnancy Warnings

The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned

Comments:
-There is no data on use in pregnant women to know this drugs risks.

Animal studies are not available. There are no controlled data in human pregnancy.


US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D, and X are being phased out.

See references

Botulism antitoxin Breastfeeding Warnings

The manufacturer makes no recommendation regarding use during lactation.

Excreted into human milk: Data not available
Excreted into animal milk: Data not available

Comments:
-There is no information regarding this drug on the presence in human milk, the effects on a breastfed infant, or effects on milk production.
-Consider the developmental and health benefits of breastfeeding along with the mother's clinical need for this medication as well as any potential adverse effects from this drug or the underlying maternal condition.
-Breastfeeding is a risk factor for infant botulism from direct exposure.
-Patients with suspected botulism poisoning should avoid breastfeeding until they have recovered.

See references

References for pregnancy information

  1. "Product Information. Botulism Antitoxin (botulism antitoxin)." sanofi pasteur, Swiftwater, PA.

References for breastfeeding information

  1. "Product Information. Botulism Antitoxin (botulism antitoxin)." sanofi pasteur, Swiftwater, PA.
  2. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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