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Hydroxyurea Pregnancy and Breastfeeding Warnings

Hydroxyurea is also known as: Droxia, Hydrea, Mylocel

Hydroxyurea Pregnancy Warnings

-This drug has been demonstrated to be a potent teratogen in a wide variety of animal models. It is embryotoxic and causes 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. This drug crosses the placenta. 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 D: There is positive evidence of human fetal risk based on adverse reaction data from investigational or marketing experience or studies in humans, but potential benefits may warrant use of the drug in pregnant women despite potential risks.

Use should be avoided. AU TGA pregnancy category: D US FDA pregnancy category: D Comments: -Drugs which affect DNA synthesis, such as this drug, may be potent mutagenic agents. -An effective method of contraception is advised in both male and female patients before and during treatment. -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.

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

-Most sources consider breastfeeding to be 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. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. "Product Information. Droxia (hydroxyurea)." Bristol-Myers Squibb, Princeton, NJ.
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):

References for breastfeeding information

  1. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL:" ([2006]):
  2. "Product Information. Droxia (hydroxyurea)." Bristol-Myers Squibb, Princeton, NJ.
  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:" ([cited 2013 -]):

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