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Bayer Still Quiet on Resolving Lawsuits Over Beyaz Side Effects

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Washington, DCWith all the hype surrounding alleged side effects associated with Yasmin and Yaz, it remains odd that concern for Beyaz side effects on the part of the manufacturer appears to have fallen through the cracks. This is equally curious given the close association of the formulation upon which Beyaz is based, to Yaz.

Yasmin and Yaz remain, in spite of the now well-publicized side effects and resulting lawsuits, two of the best-selling oral contraceptives in the world - a plateau due in part to clever marketing to young women looking for alternatives to common side effects of early-generation contraceptives, including bloating. Not only did Yaz and Yasmin promise to mitigate water retention and weight gain, there was the added value of benefits against moderate acne and other “perks.”

The concept of added value was furthered through the introduction of Beyaz, which is really just Yaz with the addition of folate, a B vitamin that helps to reduce the potential for neural tube defects in newborns. The idea is for women to supplement with folate during their child-bearing years - the time at which they would employ birth control, and the time at which they might become pregnant.

The problem, or so it has been alleged, is that Yaz and Yasmin - and Beyaz by default - are based on the synthetic drospirenone, a third-generation formulation that helps to deliver the benefits touted by manufacturer Bayer. However, there is also a greater risk for Beyaz blood clots than that associated with older birth control pills.

The potential for blood clots has always been associated with birth control pills from the very beginning. And the warnings were always there. However, over the years, the popularity and growth of oral contraceptives together with a low incidence of blood clots succeeded in pushing the potential for blood clots completely from the radar. And at all times, ever since oral contraceptives were first approved by the US Food and Drug Administration (FDA) in the 1950s, the benefit of reduced incidence for unwanted pregnancy was thought to outweigh any risks.

That was the status quo until drospirenone came along in Yasmin, Yaz and eventually Beyaz drospirenone. Suddenly, there were increasing reports of women - including very young women - experiencing debilitating and sometimes fatal blood clots.

Given the huge sales associated with Yasmin and Yaz, the majority of lawsuits have centered on the duo, together with an increasing public awareness of the potential dangers of drospirenone. For its part, the FDA, while acknowledging that studies are not entirely definitive, has nonetheless taken the position that an increased risk for blood clots over older, first- and second-generation birth control pills does, indeed, exist.

Bayer has, and continues to maintain, that its third-generation products carry no greater risk for blood clots than other birth control pills.

Given that Beyaz is Yaz with the simple addition of folate under a different wrapper, the risks are similar. Thus, side effects of Beyaz include the risk for blood clots.

And yet, Bayer appears to be fixated upon Yasmin and Yaz, while allowing any lawsuits for Beyaz to languish. Is that because the number of lawsuits for Yaz and Yasmin dwarf those of Beyaz birth control? Plaintiffs who have suffered from Beyaz bleeding (blood clots) advocate they shouldn’t be left in the shadows just because they happened to choose a product that pales in sales volume to its more imposing and successful siblings.

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