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First, the FDA has four basic designations regarding product use in pregnancy: (A) Controlled studies show no risk. Adequate, well-controlled studies in pregnant women have failed to demonstrate risk to the fetus. (B) No evidence of risk in humans. Either animal findings show risk, but human findings do not; or, if no adequate human studies have been done, animal findings are negative. (C) Risk cannot be ruled out. Human studies are lacking, and animal studies are either positive for fetal risk or lacking as well. However, potential benefits may justify the potential risk. (D) Positive evidence for risk. Investigational or post-marketing data show risk to the fetus. Nevertheless, potential benefits may outweigh the potential risk. (X) Contraindicated in pregnancy. Studies in animals or humans, or investigational or post-marketing reports, have shown fetal risk which clearly outweighs any possible benefit to the patient. Acne acceleration is probably our most common occurrence. Which products are safe in early pregnancy for treatment of acne? First, Retin A® or tretinoin is category C, due to lack of clinical studies. Most likely it is quite safe, but complete data is not available. Of course, Accutane is category X, due to its severe birth defect causing side effects. In fact, fetal damage has occurred with as low as ONE dose. Topical Therapy is the best method of treatment of acne in pregnancy. Topical erythromycin,metronidazole, clindamycin and benzoyl peroxide have recently been recommended as the treatment of choice in a recent review. (Koren G, Pastiszak A. Itu S. Drugs in Pregnancy. New England Journal of Medicine 1998; 338: 1128-1137.) Each of these topical antibiotics is minimally absorbed and safe for lactating females. Tretinoin (Retin A® ) is also safe in pregnancy and lactation. Azelex is safe (pregnancy category C) in pregnancy and lactation, with only 4% topical absorption. Tazarac® (tazarotene) is pregnancy category X and should not be used in either pregnant or lactating females. All glycolic acid products are safe in pregnancy and lactation. Hydroquinone topically applied is also safe (category C). Thus, most of the products available for acne treatment other than Accutane and Tazorac are safe for use in pregnancy. Topical therapy is the preferred route of medication administration.
Are you planning on having facial surgery? We have put together two excellent kits for our Pre and Postop clients. Read about both of these programs -- plus the protocols that we uses to prevent scarring, bleeding and swelling when he does laser resurfacing.
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