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Perflutren Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Mar 11, 2021.

Perflutren is also known as: Definity, Definity RT, Optison

Perflutren Pregnancy Warnings

Animal studies in rats and rabbits at considerably higher doses than the recommended maximum human dose showed no significant findings on the fetus.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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.

This drug should be used in pregnancy only if clearly needed.

AU TGA pregnancy category: B1
US FDA pregnancy category: Unassigned

Risk Summary: There is no data that suggests a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

See references

Perflutren Breastfeeding Warnings

Benefit should outweigh risk.

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 references

References for pregnancy information

  1. "Product Information. Optison (perflutren)." Mallinckrodt Medical Inc, St. Louis, MO.
  2. TGA. Therapeutic Goods Administration. Australian Drug Evaluation Committee "Prescribing medicines in pregnancy: an Australian categorisation of risk of drug use in pregancy. Available from: URL: http://www.tga.gov.au/docs/pdf/medpreg.pdf." ([1999]):
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. "Product Information. Definity (perflutren)." Lantheus Medical Imaging Inc, North Billerica, MA.

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  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 -]):
  3. "Product Information. Definity (perflutren)." Lantheus Medical Imaging Inc, North Billerica, MA.
  4. "Product Information. Optison (perflutren)." Mallinckrodt Medical Inc, St. Louis, MO.

Further information

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