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I’m looking for the drug/teratogen category for sodium bisulfite. Is it a category A or B class drug?
The US Food and Drug Administration (FDA) assigns pregnancy categories to drugs that are subject to FDA approval. Current pregnancy labeling uses five categories—A, B, C, D, and X. The categories may mislead healthcare providers (and the women they counsel) to believe that risk increases from category A to B to C to D to X. In fact, that is not the case, because Categories C, D, and X are based not just on risk, but risk weighed against benefit. In addition, the categories do not always distinguish between risks based on human versus animal data findings. The categories do not always reflect human data on pregnancy exposure and therefore their usefulness is limited. The FDA is currently in the process of revising the categories in favor of something that is more clinically useful to providers and their patients.
Sodium bisulfite is not a medication so it does not have a pregnancy category associated with it. Sodium bisulfite is used as a bleach and disinfectant in industry and cosmetics. Sulfites are commonly used food additives to prevent spoilage and discoloration. To date there have been no reports associating sodium bisulfite with adverse pregnancy outcome.
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