Weighing The Pros and Cons of Natazia

Washington, DCIn today's crowded pharmaceutical universe, one indication for treatment which sets one drug apart from the others provides the manufacturer with an integral marketing tool by which to attract attention from an increasingly distracted public. Bayer's Natazia is one such product.

When Bayer launched Yasmin and Yaz several years ago, the third-generation oral contraceptives were aimed at young women worried about acne and weight gain. Bayer's claims that the Yaz / Yasmin duo would serve to help combat those two scourges—as well as provide contraceptive protection from unwanted pregnancy—drove the younger female demographic to Yasmin and Yaz in droves. Whether or not those claims were accurate is beside the point: Bayer succeeded in the creation of an image that attracted young women concerned about their appearance. Yasmin and Yaz were two contraceptives they could relate to.

Now Bayer has Natazia, a more recent oral contraceptive that carries yet another valued indication or added benefit that sets this oral contraceptive apart from the others.

In the case of Natazia, it's heavy menstrual bleeding—a condition that plagues many women from a wide variety of demographics. Such heavy periods can adversely affect women in numerous ways, according to a randomized study conducted in 2011 that looked at various treatment options as part of a larger focus on Natazia—a four-phase, estrogen step-down, progestin step-up regimen that contains the estrogen estradiol valerate and the progestin dienogest.

As summarized in Contraceptive Technology Update (06/01/12) , upwards of three million women experience heavy menstrual bleeding each year. Thus, the push to source additional treatments to afford women more options, but also to tap into a wide market.

"As the first oral contraceptive treatment approved for heavy menstrual bleeding in women without organic pathology who choose an [oral contraceptive] for contraception, Natazia represents a new treatment approach for appropriate women with this medical condition," touted Pamela Cyrus MD, Bayer HealthCare vice president and head of US medical affairs in a statement accompanying the approval for heavy menstrual bleeding earlier this year.

For the latter indication, Natazia appears to be effective. About 75 per cent of the treatment group and 85.7 per cent of the placebo group had heavy bleeding at baseline, the study revealed. Resolution was seen in 56 per cent and 26.7 per cent of study participants, respectively. An identical study in Europe appears to back up the North American findings, with successful treatment of heavy menstrual bleeding in 63.6 per cent of the treatment group, but only 11.9 per cent of the placebo group.

But at what price? The achievement of less-severe menstrual bleeding appears to come at a cost of increased risk for blood clots—so much so that the US Food and Drug Administration (FDA) issued a black box warning a month before the new indication was formally approved by the regulator.

Natazia has been on the market since 2010, but the indication for heavy menstrual bleeding was given the nod just this past March. Industry experts will be watching to see if instances of blood clot and deep vein thrombosis spike in the ensuing months, as Natazia is adopted as the contraceptive of choice for women seeking relief from heavy menstrual bleeding.

In so doing, they run the risk of posing additional problems for themselves, if blood clots come calling…