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  • The combined oral contraceptive pill containing drospirenone and ethinyl estradiol plus levomefolate calcium.

The combined oral contraceptive pill containing drospirenone and ethinyl estradiol plus levomefolate calcium.

Expert opinion on pharmacotherapy (2011-09-01)
Rachel B Rapkin, Mitchell D Creinin
ABSTRACT

Neural tube defects are the second most common congenital anomaly in the United States, although their incidence may be decreased by periconception folic acid supplementation. A new oral contraceptive containing drospirenone and ethinyl estradiol plus levomefolate calcium was formulated to decrease the risk of neural tube defects in pregnancies conceived while taking or shortly after discontinuing this pill. Because of its novelty, very few studies have been performed to evaluate the efficacy, side effects and safety related to contraception, premenstrual dysphoric disorder and acne; therefore, literature evaluating similar contraceptives without levomefolate is reviewed. Additionally, we review studies evaluating the addition of levomefolate calcium to oral contraceptives containing 3 mg drospirenone and either 20 or 30 μg ethinyl estradiol. To date, no study has been performed to evaluate the effect this new oral contraceptive has on reducing the incidence of neural tube defects. This new pill has similar contraceptive efficacy, side effect, safety and benefits profile to other drospirenone-containing contraceptives. While also approved to prevent neural tube defects, no studies validate this claim and physician time is better spent counseling women, regardless of contraceptive choice, on the importance of folic acid supplementation during the child-bearing years.

MATERIALS
Product Number
Brand
Product Description

Sigma-Aldrich
17α-Ethynylestradiol, ≥98%
Ethinylestradiol, European Pharmacopoeia (EP) Reference Standard
Supelco
17α-Ethynylestradiol solution, 1.0 mg/mL in methanol, ampule of 1 mL, certified reference material, Cerilliant®
Drospirenone, European Pharmacopoeia (EP) Reference Standard
Sigma-Aldrich
Drospirenone, ≥98% (HPLC)
Supelco
Ethinyl Estradiol, Pharmaceutical Secondary Standard; Certified Reference Material
USP
Ethinyl estradiol, United States Pharmacopeia (USP) Reference Standard
Ethinylestradiol for system suitability, European Pharmacopoeia (EP) Reference Standard