levomefolate-calcium and Neural-Tube-Defects

Beyaz(®) (Bayer HealthCare Pharmaceuticals, Berlin, Germany) consists of 28 film-coated tablets: 24 tablets each containing 3 mg drospirenone plus 20 µg ethinylestradiol (EE) and 451 µg levomefolate calcium followed by four tablets, each containing 451 µg levomefolate calcium. It has the same indications of the parent compound 20 µg EE/3 mg drospirenone in a 24/4-day regimen (i.e., contraception, moderate acne, premenstrual dysforic disorder). In addition, the 24-day regimen with 20 µg EE/3 mg drospirenone/levomefolate calcium assure significant increases in red blood cell and plasma folate levels reaching values indicated to be protective in reducing the risk of neural tube defects. A progressive decrease in folate levels has been observed in women taking a 30 µg EE pill fortified with the same dose of levomefolate calcium upon discontinuation. At 4 and 8 weeks following cessation of the oral contraceptive, red blood cell folate levels >906 nmol/l were measured in 85 and 60% of women respectively. Because of this, the folate-containing pill may aid in reducing the risk of neural tube defects in a pregnancy conceived during use or shortly after the discontinuation of the product.

Topics: Androstenes; Calcium; Contraception; Contraceptives, Oral, Combined; Drug Administration Schedule; Ethinyl Estradiol; Evidence-Based Medicine; Female; Glutamates; Humans; Neural Tube Defects; Patient Satisfaction; Tetrahydrofolates

The incidence of pregnancies affected with neural tube defects (NTDs) has been reduced by food fortification programs and public health campaigns promoting folic acid supplementation, but the incidence of NTDs in the USA has not achieved the full potential reduction expected with adequate periconceptional folate utilization. In seeking new ways to access sexually active women at risk for pregnancy, one option would be to link folic acid supplementation to contraceptive use. Since birth control pills are the most popular method of reversible contraception in the USA, it would seem quite logical to find a way to supplement them. To this end, a very efficient folate, levomefolate calcium salt (metafolin), has been added to drospirenone-containing oral contraceptives in equimolar concentrations to the recommended supplements of folic acid to reduce the risk for pregnancy and to reduce the risk of NTDs in pregnancies that occur while women are taking the pill or shortly after they discontinue its use. This article will focus on the need for such folate supplementation and will summarize the contraceptive and noncontraceptive benefits of the 30 µg EE/3 mg drospirenone pill (Yasmin(®), Bayer Healthcare, NJ, USA) to which has been added 451 metafolin (Safyral(®), Bayer Healthcare). The new information about thromboembolism risks associated with use of drospirenone-containing pills is also discussed.

Topics: Androstenes; Calcium; Contraception; Contraceptives, Oral, Hormonal; Drug Administration Schedule; Ethinyl Estradiol; Evidence-Based Medicine; Female; Folic Acid; Glutamates; Humans; Neural Tube Defects; Pregnancy; United States; Women's Health

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.

Topics: Androstenes; Calcium; Contraceptives, Oral, Combined; Ethinyl Estradiol; Female; Glutamates; Humans; Neural Tube Defects

This study investigated the effects of adding levomefolate calcium 0.451 mg (the calcium salt of L-5-methyltetrahydrofolate; Metafolin®) to an oral contraceptive containing ethinylestradiol (EE) 20 mcg/drospirenone (drsp) 3 mg on folate levels in healthy women seeking contraception.. In this randomized, double-blind, multicenter US-based study, women (18-40 years) received 24 weeks (six cycles) of EE/drsp/levomefolate calcium or EE/drsp for 24 days followed by 4 days of levomefolate calcium alone or placebo, respectively. The primary efficacy variables were red blood cell (RBC) and plasma folate levels at 24 weeks.. At week 24, increases from baseline in mean RBC (990 ± 390 nmol/L to 1406 ± 440 nmol/L) and plasma folate (45.0 ± 17.6 nmol/L to 60.8 ± 19.9 nmol/L) levels were observed in women who received EE/drsp/levomefolate calcium [per protocol set (n=262); all values are displayed as mean ± standard deviation]. In contrast, marginal fluctuations were observed with EE/drsp (p<.0001 for between-treatment differences at week 24).. Clinically significant increases in folate status were observed with EE/drsp/levomefolate calcium compared with EE/drsp alone in US women of childbearing age.

Topics: Adolescent; Adult; Androstenes; Calcium; Contraceptives, Oral; Double-Blind Method; Estrogens; Ethinyl Estradiol; Female; Folic Acid; Glutamates; Homocysteine; Humans; Mineralocorticoid Receptor Antagonists; Neural Tube Defects; Treatment Outcome; Young Adult