DEFEROXAMINE
Drugs in Pregnancy and Lactation.
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Name: DEFEROXAMINE
Class: Chelating Agent
Risk Factor: CM
Fetal Risk Summary
Deferoxamine is used for the treatment of acute iron intoxication and chronic iron overload. Animal reproduction studies have shown delayed ossification in mice and skeletal anomalies in rabbits with daily doses up to 4.5 times the maximum daily human dose (1). No fetal adverse effects were observed in rats administered similar doses (1).
In another animal reproduction study, pregnant mice were administered intraperitoneal doses of deferoxamine (44, 88, 176, and 352 mg/kg/day) on gestational days 6 through 15 and then sacrificed on gestational day 18 (2). On a weight basis, the lower two doses are comparable to the therapeutic human dose. The NOAEL (no observed adverse effect level) for maternal toxicity (reduced body weight) was <44 mg/kg/day, whereas the NOAEL for fetal developmental toxicity was 176 mg/kg/day (2). The only fetal toxic effect was a decrease in the number of live fetuses that was observed at 352 mg/kg/day.
A number of reports have described the use of deferoxamine in human pregnancy either for acute iron overdose or for transfusion-dependent thalassemia (3,4,5,6,7 and 8). Brief mention of three other pregnant patients treated with deferoxamine for acute overdose appeared in an earlier report, but no details were given except that all of the infants were normal (9). The authors have knowledge of a seventh patient treated in the 3rd trimester for overdose with normal outcome (S.M. Lovett, unpublished data, 1985).
In a thalassemia patient, deferoxamine was given by continuous subcutaneous infusion pump, 2 g every 12 hours, for the first 16 weeks of pregnancy (3). A cesarean section was performed at 33 weeks' gestation for vaginal bleeding and premature rupture of the membranes, with delivery of a normal preterm male infant. The neonatal period was complicated by hypoglycemia and prolonged jaundice lasting 6 weeks, but neither problem was thought to be related to deferoxamine. A 1999 report described the use of deferoxamine in an 18-year-old pregnant woman with hemoglobin E beta zero thalassemia, chronic hepatitis C, and iron overload (4). She conceived while receiving a SC dose of 40 mg/kg four days a week plus an additional 50 mg/kg IV every month with a transfusion. Therapy was stopped when the pregnancy was diagnosed, but then restarted at 18 weeks' gestation because of increased iron accumulation. The dose was increased in increments in response to her high ferritin levels, eventually reaching 50 mg/kg/day IV. She delivered an approximate 2298-g, normal male infant at 38 weeks' gestation. The boy was developing normally at 10 months of age and no toxic effects on bone formation, auditory, or ocular systems were found (4).
Several pregnant women have received deferoxamine therapy for iron overdose that occurred at 15 to 38 weeks' gestation (5,6,7 and 8). The women were treated with IM deferoxamine, and one also received the drug nasogastrically. Spontaneous labor with rupture of the membranes occurred 8 hours after iron ingestion in a 34-week gestation patient, resulting in the vaginal delivery 6 hours later of a normal male infant (5). The cord blood iron level was 121 µg/dL (normal 106–227 µg/dL) but fell to 21 µg/dL at 12 hours. The infant's clinical course was normal except for low iron levels requiring iron supplementation. The authors suggested that the low neonatal iron levels were due to chelation of iron by transplacentally transferred deferoxamine. In another case, a normal term male infant was delivered without evidence of injury from deferoxamine (6). Normal infants were delivered also in the other two cases, both at times distant from the use of deferoxamine (7,8).
In summary, deferoxamine produces toxicity and teratogenicity in various animal species. Although the number of published human pregnancy exposures to deferoxamine is limited, none of the reports have observed adverse human developmental effects. In one the reports discussed above, the authors reviewed over 65 cases of human pregnancy exposure to the agent that occurred during the management of thalassemia or iron overdose (4). No toxic or teratogenic effects were documented. A 1998 review of metal chelating agents also failed to find any published evidence of human developmental toxicity (10).
Breast Feeding Summary
No reports describing the use of deferoxamine in lactation have been located. The molecular weight (about 657) is low enough that some excretion into breast milk probably occurs. The effects, if any, on a nursing infant from this exposure are unknown.
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References
- Product information. Desferal. Novartis Pharmaceuticals, 2000.
- Bosque MA, Domingo JL, Corbella J. Assessment of the developmental toxicity of deferoxamine in mice. Arch Toxicol 1995;69:467–71.
- Thomas RM, Skalicka AE. Successful pregnancy in transfusion-dependent thalassemia. Arch Dis Child 1980;55:572–4.
- Singer ST, Vichinsky EP. Deferoxamine treatment during pregnancy: is it harmful? Am J Hematol 1999;60:24–26.
- Rayburn WF, Donn SM, Wulf ME. Iron overdose during pregnancy: successful therapy with deferoxamine. Am J Obstet Gynecol 1983;147:717–8.
- Blanc P, Hryhorczuk D, Danel I. Deferoxamine treatment of acute iron intoxication in pregnancy. Obstet Gynecol 1984;64:12S–4S.
- Van Ameyde KJ, Tenenbein M. Whole bowel irrigation during pregnancy. Am J Obstet Gynecol 1989;160:646–7.
- Lacoste H, Goyert GL, Goldman LS, Wright DJ, Schwartz DB. Acute iron intoxication in pregnancy: case report and review of the literature. Obstet Gynecol 1992;80:500–1.
- Strom RL, Schiller P, Seeds AE, Ten Bensel R. Fatal iron poisoning in a pregnant female: case report. Minn Med 1976;59:483–9.
- Domingo JL. Developmental toxicity of metal chelating agents. Reprod Toxicol 1998;12:499–510.
Q&A about Deferoxamine
jus check serum iron levels..
they'll be high in thalassemic patients..
more so atr even a single transfusion..
