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Sodium thiosulfate Pregnancy and Breastfeeding Warnings

Brand names: Pedmark

Sodium thiosulfate Pregnancy Warnings

This drug should be used during pregnancy only if the benefit outweighs the risk to the fetus.

AU TGA pregnancy category: Not formally assigned to a pregnancy category.
US FDA pregnancy category: Not assigned.

Risk summary: No data using clinically relevant doses are available on the use of this drug in pregnant patients to inform a drug-related risk.

Comments:
-Concerns about adverse effects on the fetus may have little relevance in the context of life threatening poisoning in the mother.

Animal studies did not show embryotoxic or teratogenic effects. 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

Sodium thiosulfate Breastfeeding Warnings

Caution is recommended.

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

Comments:
-Concerns about adverse effects on the breastfed infant may have little relevance in the context of life threatening poisoning in the mother.
-There is no information on when breastfeeding may be safely resumed after treatment.

See references

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References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information."
  2. (2015) "Product Information. Sodium Thiosulfate (sodium thiosulfate)." American Regent Laboratories Inc
  3. (2022) "Product Information. Pedmark (sodium thiosulfate)." Fennec Pharmaceuticals, Inc.
  4. (2023) "Product Information. Sodium Thiosulfate (sodium thiosulfate)." Hope Pharmaceuticals

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information."
  2. (2015) "Product Information. Sodium Thiosulfate (sodium thiosulfate)." American Regent Laboratories Inc

Further information

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