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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FDA Approves Additional Use for IUD Mirena to Treat Heavy Menstrual Bleeding in IUD Users

/PRNewswire/ -- The U.S. Food and Drug Administration today approved Mirena (levonorgestrel intrauterine system) to treat heavy menstrual bleeding in women who use intrauterine contraception as their method of pregnancy prevention. This is the first intrauterine device approved by the FDA for this additional indication.

Mirena was approved as a contraceptive by the FDA in 2000. It is a small, flexible hormone-releasing device inserted into the uterus to prevent pregnancy. The device should be inserted by a trained health care professional.

"Women who suffer heavy, prolonged menstrual periods find the condition unpleasant, disabling, and frightening," said Kathleen Uhl, M.D., director of the FDA's Office of Women's Health. "Bleeding can be so heavy that women must miss work, school, or social activities."

"In the primary clinical trial, women using Mirena showed a statistically significant reduction in menstrual blood loss," said Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research.

Participants in the clinical trial had excessive menstrual blood loss prior to treatment and did not have any medical conditions that are known to cause heavy menstrual bleeding, except for small uterine fibroids in some cases.

Mirena is recommended for women who have had a child. Clinical studies to support both the contraception and heavy menstrual bleeding indications have excluded women who have never been pregnant.

Since its approval in 2000, the most serious adverse reactions reported in patients using Mirena for any indication include: ectopic pregnancy (a pregnancy in which the fertilized egg grows outside the uterus); intrauterine pregnancy (a pregnancy with Mirena in place); group A streptococcal sepsis; an infection called pelvic inflammatory disease; embedment of the device in the uterine wall; and perforation of the uterine wall or cervix.

The most common adverse events reported by patients in the primary clinical trial using Mirena to treat heavy menstrual bleeding included uterine bleeding/spotting at irregular intervals, headache, ovarian cysts, vaginitis, pain during menstruation (dysmenorrhea), pelvic pain, and breast tenderness.

Mirena is made by Bayer HealthCare Pharmaceuticals, Inc., Wayne, N.J.

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