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Aluminum hydroxide Pregnancy and Breastfeeding Warnings

Aluminum hydroxide is also known as: Aloh-Gel, Alternagel, Alu-Cap, Alu-Tab, Amphojel, Dialume

Aluminum hydroxide Pregnancy Warnings

Aluminum hydroxide has not been formally assigned to a pregnancy category by the FDA. There are no controlled data in human pregnancy, however, limited data suggest no association between aluminum hydroxide and adverse fetal outcome (written communication, Franz Rosa, MD, Food and Drug Administration, 1994). Aluminum hydroxide is only recommended for use during 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 anytime 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, and 1 polydactyly. These data do not support an association between aluminum hydroxide ingestion and adverse fetal outcome (written communication, Franz Rosa, MD, Food and Drug Administration, 1994).

Aluminum hydroxide Breastfeeding Warnings

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

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