Gadopentetate Dimeglumine Risk Summary

Risk Factor: CM
Class: Diagnostic agents

Fetal Risk Summary

Gadopentetate dimeglumine is an IV paramagnetic contrast agent used for magnetic resonance imaging. Although no congenital malformations were observed, doses 2.5 times the human dose in rats and 7.512.5 times the human dose in rabbits resulted in slight retardation of development (1).

Gadopentetate dimeglumine crosses the placenta to the fetus in rabbits (2). Pregnant rabbits were given 0.1 mmol/kg IV in the 3rd trimester. Drug concentrations (g/g) in fetal tissues at 5 and 60 minutes were placenta (16.6 and 6.1), liver (2.8 and 1.6), brain (0.4 and 0.6), muscle (3.2 and 3.9), heart (2.2 and 3.1), and kidneys (4.3 and 6.8). The amounts in the placenta and kidneys were sufficient for imaging and possibly for fetal toxicity (2).

A 1992 case report described the inadvertent IV bolus administration of gadopentetate dimeglumine (0.2 mmol/kg) to a woman with multiple sclerosis shortly after conception (3). Her last menstrual period had occurred 23 days before the magnetic resonance imaging procedure, thus giving her an estimated gestational length of 9 days. Because this was before the period of organogenesis, the authors of the report concluded that the most likely adverse effect would have been an early spontaneous abortion, rather than congenital malformations. A normal pregnancy occurred, however, terminating in the delivery of a healthy baby girl at 39 weeks' gestation. The infant was developing normally at 3 months of age (3).

Breast Feeding Summary

Gadopentetate dimeglumine is excreted in small amounts in the milk of lactating rats given a dose of 5 mmol/kg (1). The manufacturer reported that less than 0.2% of the total dose was transferred to the nursing pups during a 24-hour period (1).

A 2000 study described the excretion of gadopentetate dimeglumine into the breast milk of 19 women (4). One woman who was undergoing magnetic resonance imaging received 0.2 mmol/kg IV (15 mmol), but the other 18 subjects received 0.1 mmol/kg (mean 5.9 mmol). Breast feeding was stopped for at least 24 hours. A mean of four (range one to seven) samples of breast milk were collected over 24 hours. The cumulative amount of drug excreted into milk over 24 hours was 0.57 mol (range 0.053.0 mol). This amount was a mean 0.009% (range 0.001%0.04%) of the mother's dose. Because the amount excreted into milk would be far less than the recommended IV dose for neonates (200 mol/kg) combined with the fact that very little of orally administered gadopentetate dimeglumine is absorbed systemically, the authors concluded that waiting 24 hours to resume breast feeding was not warranted (4).

References

1. Product information. Magnevist. Berlex Laboratories, 1993.
2. Novak Z, Thurmond AS, Ross PL, Jones MK, Thornburg KL, Katzberg RW. Gadilinium-DTPA transplacental transfer and distribution in fetal tissue in rabbits. Invest Radiol 1993;28:82830.
3. Barkhof F, Heijboer RJJ, Algra PR. Inadvertent IV administration of gadopentetate dimeglumine during early pregnancy. AJR 1992;158:1171.
4. Kubik-Huch RA, Gottstein-Aalame NM, Frenzel T, Seifert B, Puchert E, Wittek S, Debatin JF. Gadopentetate dimeglumine excretion into human breast milk during lactation. Radiology 2000;216:5558.

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