FDA Approves Combination Contraceptive Containing a Folate

/PRNewswire/ -- The U.S. Food and Drug Administration on Friday approved Beyaz tablets, an estrogen/progestin combined oral contraceptive that also contains a folate (levomefolate calcium 0.451 mg).

Levomefolate calcium is a metabolite of folic acid, a water-soluble B-vitamin that helps produce and maintain new cells in the body. A known association of low folate levels and neural tube defects (e.g., spina bifida) has resulted in recommendations that women of childbearing age supplement their diet with folate.

Beyaz is based on the approved product YAZ, which contains the same doses of estrogen and progestin, and is approved for:

* Prevention of pregnancy
* Treatment of symptoms of premenstrual dysphoric disorder (PMDD) in women who choose to use an oral contraceptive for contraception and
* Treatment of moderate acne vulgaris in women at least 14 years of age, only if the patient desires an oral contraceptive for birth control.


In addition to the approved YAZ indications, Beyaz also is approved for the secondary indication in women who choose to use an oral contraceptive as their method of contraception, to raise folate levels for the purpose of reducing the risk of a neural tube defect in a pregnancy conceived while taking the product or shortly after discontinuing the product.

The primary efficacy study for Beyaz was a multicenter, double-blind, randomized, controlled U.S. trial in 379 healthy women age 18 to 40 who were treated with Beyaz or YAZ alone for up to 24 weeks. Beyaz was found to increase folate levels in women. In a German study of Beyaz, folate levels remained elevated for several weeks following discontinuation of Beyaz. Safety and efficacy data for contraception, PMDD, and acne indications were obtained from previous YAZ clinical trials.

The most common side effects reported by users of combined oral contraceptives are irregular uterine bleeding, nausea, breast tenderness, and headaches. Other serious side effects include vascular events (blood clots) and liver disease. Women over age 35 who smoke should not use this product as cigarette smoking increases further the risk of serious cardiovascular events. The common adverse events for Beyaz are expected to be the same as those for YAZ. There were no findings from the clinical trials with Beyaz to suggest a change in the overall safety profile compared to that of YAZ.

Beyaz is manufactured by Bayer HealthCare Pharmaceuticals Inc., the U.S.-based business arm of Bayer HealthCare LLC, a subsidiary of Bayer AG.

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Folic Acid May Help Treat Allergies, Asthma

Folic acid, or vitamin B9, essential for red blood cell health and long known to reduce the risk of spinal birth defects, may also suppress allergic reactions and lessen the severity of allergy and asthma symptoms, according to new research from the Johns Hopkins Children's Center.

In what is believed to be the first study in humans examining the link between blood levels of folate -- the naturally occurring form of folic acid -- and allergies, the scientists say results add to mounting evidence that folate can help regulate inflammation. Recent studies, including research from Johns Hopkins, have found a link between folate levels and inflammation-mediated diseases, including heart disease. A report on the Johns Hopkins Children's findings appears online ahead of print in the Journal of Allergy & Clinical Immunology.

Cautioning that it's far too soon to recommend folic acid supplements to prevent or treat people with asthma and allergies, the researchers emphasize that more research needs to be done to confirm their results, and to establish safe doses and risks.

Reviewing the medical records of more than 8,000 people ages 2 to 85 the investigators tracked the effect of folate levels on respiratory and allergic symptoms and on levels of IgE antibodies, immune system markers that rise in response to an allergen. People with higher blood levels of folate had fewer IgE antibodies, fewer reported allergies, less wheezing and lower likelihood of asthma, researchers report.

"Our findings are a clear indication that folic acid may indeed help regulate immune response to allergens, and may reduce allergy and asthma symptoms," says lead investigator Elizabeth Matsui, M.D., M.H.S., pediatric allergist at Johns Hopkins Children's. "But we still need to figure out the exact mechanism behind it, and to do so we need studies that follow people receiving treatment with folic acid, before we even consider supplementation with folic acid to treat or prevent allergies and asthma."

The current recommendation for daily dietary intake of folic acid is 400 micrograms for healthy men and non-pregnant women. Many cereals and grain products are already fortified with folate, and folate is found naturally in green, leafy vegetables, beans and nuts.

Other findings of the study:

People with the lowest folate levels (below 8 nanograms per milliliter) had 40 percent higher risk of wheezing than people with the highest folate levels (above 18 ng/ml).
People with the lowest folate levels had a 30 percent higher risk than those with the highest folate levels of having elevated IgE antibodies, markers of allergy predisposition.
Those with the lowest folate levels had 31 percent higher risk of atopy (allergic symptoms) than people with the highest folate levels.
Those with lowest folate levels had 16 percent higher risk of having asthma than people with the highest folate levels.
Blacks and Hispanics had lower blood folate levels - 12 and 12.5 nanograms per milliliter, respectively - than whites (15 ng/ml), but the differences were not due to income and socio-economic status.

The Johns Hopkins team is planning a study comparing the effects of folic acid and placebo in people with allergies and asthma.

Asthma affects more than 7 percent of adults and children in the United States, and is the most common chronic condition among children, according to the Centers for Disease Control and Prevention. Environmental allergies are estimated to affect 25 million Americans, according to the CDC.

Co-investigator on the study: William Matsui, M.D, of the Johns Hopkins Kimmel Cancer Center.

The research was funded by the National Institutes of Health.

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