Gold sodium thiomalate Pregnancy and Breastfeeding Warnings

Brand names: Aurolate, Myochrysine

Gold sodium thiomalate Pregnancy Warnings

Gold sodium thiomalate has been assigned to pregnancy category C by the FDA. 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 gold sodium thiomalate and other gold salts is considered contraindicated. Women of childbearing age should be warned of the potential risks of gold sodium thiomalate 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 core 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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Gold sodium thiomalate Breastfeeding Warnings

Gold sodium thiomalate and other gold salts are excreted into human milk. The manufacturer recommends that due to the potential for serious adverse reactions in nursing infants, a decision should be made to discontinue nursing or discontinue the drug, taking into account the importance of the drug to the mother. Gold sodium thiomalate is considered compatible with breast-feeding by the American Academy of Pediatrics.

In one 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. The infant's 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.

In another study, two lactating women were administered gold sodium thiomalate by intramuscular injection. The first patient received a 20 mg dose followed by a 50 mg dose 3 days later. Milk gold concentrations ranged from 17 ng/mL to a maximum of 153 ng/mL, the latter being measured 22 hours after the second dose. The second patient received a 10 mg dose followed by two 20 mg doses at three-day intervals. Milk gold concentrations ranged from 10 to 185 ng/mL, the latter being measured 3 hours after the last dose.

More recently, another study followed maternal serum and milk gold concentrations in a nursing mother administered four monthly doses of gold sodium thiomalate 10 mg intramuscularly. Milk concentrations ranged from 15 to 93 ng/mL. The milk to plasma ratio was variable, ranging from 0.02 to 0.3. On day 72 of therapy, a serum gold concentration of 51 ng/mL was measured in the infant. No adverse effects, clinical, biochemical, or hematological, occurred in the nursing infant.

Other investigators in 1987 evaluated the pharmacokinetics of another gold salt, 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. The infant's plasma and urine gold concentrations were below the level of detection (<0.0005 ng/mL) at all times tested.

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Further information

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