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Hydroxyurea Pregnancy and Breastfeeding Warnings

Hydroxyurea is also known as: Droxia, Hydrea, Mylocel, Siklos

Hydroxyurea Pregnancy Warnings

Animal studies have revealed evidence of embryotoxicity and teratogenicity. This drug can cause fetal malformations (partially ossified cranial bones, absence of eye sockets, hydrocephaly, bipartite sternebrae, missing lumbar vertebrae). Embryotoxicity was characterized by decreased fetal viability, reduced live litter sizes, and developmental delays. There are no controlled data in human pregnancy.

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.

Use should be avoided.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: This drug can cause fetal harm based on animal studies and the mechanism of action. It affects DNA synthesis may be a potential mutagenic agent.

Comments:
-Verify the pregnancy status of females of reproductive potential prior to initiating therapy.
-If this drug is used during pregnancy or if a patient becomes pregnant while taking this drug, the patient should be apprised of the potential harm to the fetus.
-Females of reproductive potential should use contraception during therapy and for at least 6 months after discontinuing therapy.
-Males of reproductive potential should use contraception during therapy and for at least 1 year after discontinuing therapy.

See references

Hydroxyurea Breastfeeding Warnings

UK: 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: Yes

Comments:
-This drug may be carcinogenetic in nursing infants.

Most experts consider breastfeeding contraindicated during maternal antineoplastic drug therapy. It might be possible to breastfeed safely during intermittent therapy with an appropriate period of breastfeeding abstinence. Although only minimal data are available to determine an appropriate period to withhold breastfeeding, the drug terminal half-live of 4.5 hours with normal kidney function suggests that withholding breastfeeding for at least 24 hours may be sufficient. This period may be longer in patients with impaired kidney function. Chemotherapy may adversely affect the normal microbiome and chemical makeup of breastmilk.

See references

References for pregnancy information

  1. "Product Information. Droxia (hydroxyurea)." Bristol-Myers Squibb, Princeton, NJ.
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  3. "Product Information. Hydroxyurea (hydroxyurea (hydroxyUREA))." Par Pharmaceutical Inc, Chestnut Ridge, NY.
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

References for breastfeeding information

  1. "Product Information. Hydroxyurea (hydroxyurea (hydroxyUREA))." Par Pharmaceutical Inc, Chestnut Ridge, NY.
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  3. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  4. 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 -]):
  5. "Product Information. Droxia (hydroxyurea)." Bristol-Myers Squibb, Princeton, NJ.

Further information

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

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