Antidote/Chelating
PREGNANCY RECOMMENDATION:Limited Human Data—Animal Data Suggest Potential Risk
BREASTFEEDING RECOMMENDATION:Potential Toxicity
Several case reports and small series have been located that describe the use of deferoxamine during pregnancy. Of these, at least 15 first-trimester exposures occurred, and no birth anomalies were described at delivery. In an additional 25 plus cases, exposures to the drug were in the second or third trimesters, and no adverse effects related to the drug were reported. The drug will probably cross the placenta, so some fetal exposure will likely occur. However, this limited human pregnancy experience prevents a complete assessment of the embryofetal risk. Animal studies did show some embryofetal toxicity in two species at doses of less than 10 times the RHD (in one species, there was maternal toxicity noted). Based on animal studies, the manufacturer recommends that women with reproductive potential use effective contraception during treatment and for 1 month after the last dose. Nevertheless, using this drug during pregnancy should be based on the pros and cons of the mother’s clinical need for treatment versus any potential fetal risk that might occur from exposure. Alternatives to this drug are deferasirox and deferiprone.
One study was located that described the use of deferoxamine in a breastfeeding mother. Breast milk levels for the drug were not obtained, but the breast milk iron levels were decreased on average by about 3-fold from the normal expected range. No adverse effects were reported in three infants exposed to deferoxamine through breastfeeding. The drug will probably be excreted into breast milk. However, the drug is poorly absorbed orally, so any infant exposure through breast milk will likely result in very low infant systemic levels. Regardless, due to a concern for potential serious adverse effects that might be seen in a breastfed infant, the manufacturer recommends that women not breastfeed while being treated with this drug and for at least 1 week after the last dose. Nevertheless, breastfeeding while using this drug should be based on the mother’s clinical need for treatment versus any potential infant risks that might occur. If used, the infant should be monitored for the most common reported adult side effects of nausea, headache, dizziness, and abdominal pain (all leading to irritability), diarrhea, lethargy, fever, rash, and low serum iron (monitor levels).