FDA Approves Second Folate-Boosted Oral Contraceptive

Posted by: admin on: June 29, 2011

Folate-Boosted Oral Contraceptive is intended to reduce the risk for rare neural tube defects in a pregnancy conceived during its use or shortly thereafter

  • The US Food and Drug Administration (FDA) has approved an oral contraceptive Safyral 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).
  • 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.
  • 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, headache/migraine, breast pain/tenderness/discomfort, nausea/vomiting, and abdominal soreness.
  • The 21/7 drospirenone 3 mg/estradiol 30 μg/levomefolate 451 μg regimen warns against its use in women smokers older than 35 years due to an increased risk for serious cardiovascular events.

 

Read More:  http://www.medscape.com/viewarticle/734688?src=mp&spon=34

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