Aurothioglucose Pregnancy and Breastfeeding Warnings

Brand names: Solganal

Aurothioglucose Pregnancy Warnings

Aurothioglucose has been assigned to pregnancy category C by the FDA. Some animal studies have revealed evidence of teratogenicity. There are no controlled data in human pregnancy. Reports on the relative safety of gold salts during pregnancy are conflicting. In general the use of aurothioglucose and other gold salts is considered contraindicated. Women of childbearing age should be warned of the potential risks of aurothioglucose during pregnancy.

The transfer of gold sodium thiomalate across the placenta has been documented. Gold deposits were detected in the liver and kidney of a 20-week fetus as well as the placenta following an elected abortion. No evidence of fetal abnormality was noted. In another case, gold sodium thiomalate 100 mg was administered intramuscularly once a month throughout pregnancy, with the last dose administered three days prior to delivery. Maternal and cord serum concentrations at delivery were 3.92 and 2.25 mcg/mL, respectively. At two and one-half weeks, the infant's gold serum concentration was 52 mcg/mL. No anomalies were noted in the infant.

Administration of gold sodium thiomalate throughout pregnancy has been associated with major congenital anomalies (i.e., hypertelorism, cleft lip/palate, occipital encephalocele, major brain abnormalities) in one infant. Some animal studies have noted similar anomalies. Normal pregnancy outcomes have been reported in the literature, as well. Until more data are available, the safety of gold salts during pregnancy remains controversial.

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Aurothioglucose Breastfeeding Warnings

Aurothioglucose and other gold salts are excreted into human milk. While the manufacturer recommends to avoid use during lactation, the American Academy of Pediatrics considers the use of aurothioglucose to be compatible with breast-feeding.

Following intramuscular administration of 135 mg of aurothioglucose, milk concentrations were 86.4 mcg/mL and 9.97 mcg/mL on two separate occasions, one week apart. Infant serum and red blood cell concentrations on the second study day were 0.712 and 0.354 mcg/mL, respectively.

A study from 1987 evaluated the pharmacokinetics of aurothioglucose in breast milk over a 20-week period. The mother began receiving weekly intramuscular injections of aurothioglucose 50 mg at four weeks' postpartum. She elected to continue to breast-feed her healthy infant. The maternal steady-state gold concentrations in plasma and breast milk were 4.05 mcg/mL and 0.04 mcg/mL, respectively. Infant plasma and urine gold concentrations were below the level of detection (<0.0005 ng/mL) at all times tested.

In another study, small amounts of gold (0.022 to 0.04 mcg/mL) were detected in breast milk following administration of gold sodium thiomalate 50 mg intramuscularly. A single 20 mg dose had been administered seven weeks earlier. Infant serum concentrations were at or below the level of detection (0.0004 mcg/mL). Three months after the last dose of gold, the infant developed facial edema which the authors possibly attributed to the gold.

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Further information

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