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Alginic acid / aluminum hydroxide / magnesium carbonate Pregnancy and Breastfeeding Warnings

Alginic acid / aluminum hydroxide / magnesium carbonate is also known as: Alenic Alka, Gaviscon Extra Relief Formula, Heartburn Antacid Extra Strength

Alginic acid / aluminum hydroxide / magnesium carbonate Pregnancy Warnings

Magnesium carbonate, aluminum hydroxide and alginic acid have not been formally assigned to a pregnancy category by the FDA. There are no controlled data in human pregnancy. Other magnesium salts (such as magnesium sulfate) have been used extensively during pregnancy in large doses with no reports of congenital defects. Magnesium carbonate, aluminum hydroxide and alginic acid should only be given in pregnancy when benefit outweighs risk.

In a review of 229,101 deliveries to Michigan Medicaid patients, 351 first-trimester exposures to aluminum hydroxide were recorded and 996 exposures any time during pregnancy. A total of 14 birth defects were reported with first trimester exposure (15 expected) and included (observed/expected) 5/4 cardiovascular defects, 2/0.5 oral clefts, 1 polydactyly, and 1 hypospadias. Data are not available for magnesium carbonate. However, for magnesium hydroxide, 341 first-trimester exposures were recorded as well as 974 exposures any time during pregnancy. A total of 14 birth defects were reported with first trimester exposure (14 expected) and included (observed/expected) 5/3 cardiovascular defects, 2/0.8 polydactyly, and one hypospadias. These data do not support an association between aluminum hydroxide or magnesium hydroxide ingestion and adverse fetal outcome. (written communication, Franz Rosa, MD, Food and Drug Administration, 1994)

Alginic acid / aluminum hydroxide / magnesium carbonate Breastfeeding Warnings

There are no data on the excretion of alginic acid, aluminum hydroxide or magnesium carbonate into human milk.

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