Betaine Pregnancy and Breastfeeding Warnings
Brand names: Cystadane
Medically reviewed by Drugs.com. Last updated on Nov 13, 2023.
Betaine Pregnancy Warnings
The manufacturer makes no recommendation regarding use during pregnancy.
AU TGA pregnancy category: Exempt
US FDA pregnancy category: Not assigned
Comments:
-There is no data on use in pregnant women to know this drugs risks, including the risk of fetal harm or reproductive effects.
Animal studies have not been conducted. There are no controlled data in human pregnancy. Limited case and post marketing reports have not identified major birth defects, miscarriage, or other adverse outcomes for the fetus or mother.
AU Exempt: Medications exempted from pregnancy classification are not absolutely safe for use in pregnancy in all circumstances. Some exempted medicines, for example the complementary medicine, St John's Wort, may interact with other medicines and induce unexpected adverse effects in the mother and/or fetus.
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.
Betaine 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.
See also
References for pregnancy information
- TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee. Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregnancy. http://www.tga.gov.au/docs/html/medpreg.htm 2010.
- Product Information. Cystadane (betaine). Recordati Rare Diseases Inc. 2018.
References for breastfeeding information
- Product Information. Cystadane (betaine). Recordati Rare Diseases Inc. 2018.
Further information
Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.
