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Aluminum hydroxide / magnesium hydroxide Pregnancy and Breastfeeding Warnings

Aluminum hydroxide / magnesium hydroxide is also known as: Alamag, ConRx AR, Maalox HRF, Maalox TC, Maldroxal, Mintox Tablets, Mylanta Ultimate Strength, Rulox 1

Aluminum hydroxide / magnesium hydroxide Pregnancy Warnings

Magnesium hydroxide and aluminum hydroxide 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 hydroxide and aluminum hydroxide 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. In addition, 341 first-trimester exposures to magnesium hydroxide were recorded and 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).

Aluminum hydroxide / magnesium hydroxide Breastfeeding Warnings

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

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