FDA Approves Oral Contraceptive Containing Folate

Posted by: admin on: June 27, 2011

 

The US Food and Drug Administration (FDA) approved an oral contraceptive — the first of its kind — that is intended both to prevent pregnancy and reduce the risk for neural tube defects in newborns if and when users of the pill give birth.

  • The new contraceptive contains levomefolate calcium, a metabolite of folic acid that helps produce and maintain new cells in the body.
  • Low folate levels in women have been linked with neural tube defects in their children such as spina bifida, resulting in recommendations that women of childbearing age supplement their diet with folate.
  • Combining an oral contraceptive with folate is important, because women may become pregnant during the use of oral contraceptive or shortly after discontinuation, possibly before seeking preconception counseling from their healthcare provider
  • It is approved for
    1. Preventing pregnancy
    2. Treating symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to prevent pregnancy with an oral contraceptive
    3. Treating moderate acne vulgaris in women at least 14 years old who desire an oral contraceptive for birth control
  • Women who choose an oral contraceptive as their method of birth control, it also raises folate levels to reduce the risk for neural tube defects in offspring.
  • Adverse effects most frequently reported by users of combined oral contraceptives are
    1. Irregular uterine bleeding
    2. Nausea
    3. Breast tenderness
    4. Headache
  • As with other oral contraceptives, it is not intended for use in women older than 35 years who smoke.

Read More:  http://www.medscape.com/viewarticle/729419?sssdmh=dm1.638971&src=nl_newsalert

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