Do We Need Vitamin-Supplemented Birth Control Pills?

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Bayer HealthCare, the manufacturer of Yaz birth control pills, won government approval for Beyaz, a new oral contraceptive that is essentially identical to Yaz but is designed to boost levels of folic acid in users. There’s an interesting irony to the ploy, since supplementation with folic acid, an essential B-vitamin, is recommended for women who are or want to be pregnant in order to avoid birth defects and neural tube defects such as spina bifida. Bayer plans to market the pill as a safeguard against complications in case women *do* become pregnant while taking it. (More on Study: Smoking During Pregnancy May Result in Uncoordinated Kids)

“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 health care provider,” wrote Dr. Anita Nelson, a professor of obstetrics and gynecology at the Harbor–University of California at Los Angeles Medical Center in a Bayer HealthCare statement.

The “perfect use” rate for preventing pregnancy with birth control pills is 99%. But few people use contraception perfectly. Doctors have calculated another rate — the “real use” rate — that reflects human errors in pill-taking and results in more limited success in preventing pregnancy. That rate is 91%, according to the Guttmacher Institute. Two common errors women make while taking the Pill: forgetting to take pills or simultaneously taking antibiotics that reduce the birth control’s effectiveness.

Aside from the addition of folic acid, Beyaz is identical to Yaz, the once bestselling oral contraceptive — marketed as “beyond birth control” — that has recently become embattled and dropped off in sales. The new pill may be a clever way to help the company sidestep the competition or simply revive a fading brand. (More on Did Johnson & Johnson Bury Data on Ortho-Evra’s Health Risks?)

In 2009, the FDA cracked down on Bayer for making misleading claims in advertisements for Yaz. In television and print commercials, the government said, Bayer overstated the pill’s benefits for acne and premenstrual syndrome. (Yaz is approved for treating only moderate acne and a severe form of premenstrual syndrome called PMDD or premenstrual dysphoric disorder.) Bayer was forced to spend $20 million to correct the misleading ads.

Meanwhile, a Danish study found that users of birth control containing the newer progestin drospirenone (contained in Yaz and its sister pill Yasmin), had a 64% higher risk of pulmonary embolism — a rare side effect involving blood clots, which can occur with any combination hormone birth control — compared wit women who used an older oral contraceptive. A separate Dutch studied backed up the finding.

The overall risk of blood clots is so low, however, that some experts said even the 64% increase was no cause for concern in most women. Still, it was scary enough to consumers to help reduce sales of Yaz — which had done more than $600 million in sales in 2008 — by 15% the following year. What’s more, at least 2,000 suits are now pending against Bayer alleging that the drug-maker did not adequately warn women about the increased risk of stroke, heart attack, blood clots and other side effects of Yaz and Yasmin.

Yaz also has a competitor at its heels: Teva Pharmaceuticals began selling a generic version of the pill Bayer liked to call “beyond birth control” in June. Bayer sued Teva.

We’ll wait to see whether Beyaz can help Bayer recover some of its lost customers and shed its bad press. For more information, see the FDA decision.

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