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Auranofin Pregnancy and Breastfeeding Warnings

Auranofin is also known as: Ridaura

Auranofin Pregnancy Warnings

The transfer of gold sodium thiomalate across the placenta has been documented. Gold deposits were detected in the liver and kidney of a 10-week fetus as well as the placenta following an elected abortion. No evidence of any fetal abnormality was noted. In another case, gold sodium thiomalate 100 mg was 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.

Auranofin 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 auranofin and other gold salts during pregnancy are conflicting. In general, the use of auranofin should be avoided during pregnancy. Women of childbearing age should be warned of the potential risks of auranofin during pregnancy.

Auranofin Breastfeeding Warnings

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's serum and red blood cell concentrations on the second study day were 0.712 and 0.354 mcg/mL, respectively. A later study 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. The infant's 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. The infant's serum concentrations were at or below the level of detection (0.004 mcg/mL). Three months after the last dose of gold, the infant developed facial edema which the authors possibly attributed to the gold.

There are no data on the excretion of auranofin into human milk. Other gold compounds are excreted into human milk. The use of auranofin during lactation is not recommended.

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