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Tazarotene topical Pregnancy and Breastfeeding Warnings

Tazarotene topical is also known as: Avage, Fabior, Tazorac

Tazarotene topical Pregnancy Warnings

Animal studies have revealed reduced fetal body weights, reduced skeletal ossification, single incidences of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. There are no controlled data in human pregnancy. Eight women inadvertently exposed to the drug during pregnancy in clinical trials gave birth to healthy babies. AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details. 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 during pregnancy only if the benefit outweighs the risk. AU TGA pregnancy category: D US FDA pregnancy category: Not assigned. Risk Summary: Based on animal studies, this drug can cause fetal harm when administered to a pregnant woman. The potential risk to the fetus outweighs the potential benefit to the mother; therefore, this drug should be discontinued as soon as pregnancy is suspected or established. In animal studies, fetal body weights and skeletal ossification were reduced when this drug was dosed topically during organogenesis at 2 times the maximum recommended human dose (MRHD). At doses 26 times the MRHD, there was a single incident of known retinoid malformations, including spina bifida, hydrocephaly, and heart anomalies. Comments: -Pregnancy testing is recommended for females of reproductive potential within 2 weeks prior to initiating therapy which should begin during a menstrual period.

See references

Tazarotene topical Breastfeeding Warnings

UK: Use is contraindicated. AU, US: A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Yes Comments: -The effects in the nursing infant are unknown. -Topical administration of this drug has not been studied during breastfeeding. -Some experts believe this drug may be safe during breastfeeding if it is not used on greater than 20% of the body surface area while nursing because of possible absorption; if it is used, the infant skin should not come into direct contact with the areas of maternal skin that have been treated and the infant should not ingest the product from the skin of the mother.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Cerner Multum, Inc. "Australian Product Information." O 0
  3. "Product Information. Tazorac (tazarotene topical)." Allergan Inc, Irvine, CA.

References for breastfeeding information

  1. 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 -]):
  2. "Product Information. Tazorac (tazarotene topical)." Allergan Inc, Irvine, CA.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

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