FDA Approves Second Folate-Boosted Oral Contraceptive

December 21, 2010 — The US Food and Drug Administration (FDA) has approved an oral contraceptive (Safyral; Bayer Healthcare Pharmaceuticals, Inc) in which 451 μg levomefolate calcium has been added to each tablet of a 21/7 drospirenone 3 mg/estradiol 30 μg regimen (Yasmin; Bayer).

As with the previously approved 24/4 folate-boosted regimen with 20 μg estrogen per active tablet (Beyaz; Bayer), the new formulation is intended to reduce the risk for rare neural tube defects in a pregnancy conceived during its use or shortly thereafter.

"Combining an oral contraceptive with folate is important, because women may become pregnant during [oral contraceptive] use or shortly after discontinuation, possibly before seeking preconception counseling from their healthcare providers," said Anita Nelson, MD, professor of obstetrics and gynecology at the Harbor–University of California–Los Angeles Medical Center in Torrance, in a company news release. "For women who already use Yasmin for contraception, Safyral offers these women a new option to receive daily folate supplementation."

FDA approval was based primarily on data from a pivotal clinical study of 379 healthy US women with access to folate-fortified food, showing that the addition of 451 μg levomefolate to a 24/4 drospirenone 3 mg/estradiol 20 μg oral contraceptive regimen significantly increased red blood cell and plasma folate levels at 24 weeks relative to the regimen alone (420 ± 347 nmol/L vs 34.3 ± 171 nmol/L and 15.8 ± 20.4 nmol/L vs −2.2 ± 14.6 nmol/L, respectively; P < .0001 for both comparisons).

Adverse events associated with use of folate-boosted oral contraceptives most commonly include premenstrual syndrome (12.4%), headache/migraine (10.3%), breast pain/tenderness/discomfort (8.1%), nausea/vomiting (4.4%), and abdominal soreness (2.2%).

As with other combination oral contraceptive regimens, the safety labeling for the 21/7 drospirenone 3 mg/estradiol 30 μg/levomefolate 451 μg regimen includes a boxed warning advising against its use in women smokers older than 35 years, citing an increased risk for serious cardiovascular events.

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