Beyaz Blood Clots: Imagine Having a Stroke at 20 Years Old

Orlando, FLThe concern over Beyaz side effects and any of the other oral contraceptives in the drospirenone family is rooted in the development of a new generation of birth control pills originally designed to mitigate a lot of the symptoms and adverse reactions common with the use of older, more traditional birth control products.

Those side effects, which have proven to be a frustration for women of child-bearing age for decades, include bloating, irregular bleeding, headaches, breast tenderness and nausea. Such adverse reactions stem from the altering of hormone levels through the use of estrogen and progestin in an effort to stop ovulation.

There has also, historically, been a risk for increased incidence of blood clots inherent with increasing estrogen levels in the body by way of birth control. Other risk factors, such as family history and obesity, can spike that risk even further. But the advent of the oral contraceptive - and the relatively small risk for blood clots - was nonetheless viewed as a massive step forward in the pursuit of birth control and family planning.

When pharmaceutical giant Bayer AG came out with Beyaz and its cousins, the dynamic - and the debate - changed. Drospirenone is a new form of progestin that first arrived on the scene with Yasmin in 2001. Yaz arrive five years later as a reformulated version of Yasmin and designed to treat mild acne and mood disorder.

In other words, Bayer sought to increase market share of its product targeted at women requiring birth control, by appealing to an individual’s vanity. A product that promised to lessen the incidence of bloating (water retention), mild acne, excessive bleeding and mood swings proved wildly appealing. Bayer was later taken to task by regulators for over-emphasizing the benefits and minimizing the risks, but the damage had already been done. Millions of women the world over were converts to Yasmin, Yaz and later Beyaz.

Beyaz birth control is essentially Yaz birth control with the addition of folate, an added benefit for women who plan to become pregnant at some stage in their lives. Folate is thought to reduce the risk for neural tube defects in infants. Despite the risks inherent with Beyaz drospirenone, Beyaz was embraced for having yet another added value above older, more traditional birth control pills.

But that comes with a cost, as Maggie Yunker discovered the hard way. According to the Orlando Sentinel (10/8/13), the then 19-year-old had been taking more traditional birth control pills for a year before her doctor advised her that switching to Yaz (Beyaz birth control, without the added folate) could help with her acne and other issues related to her period.

A year later Yunker, then 20, suffered a life-threatening stroke. The cause? Blood clots associated with her Yaz birth control pills. Had she decided to include folate in her program, that Yaz could have easily been Beyaz. And then we would be talking about Beyaz blood clots.

The side effects of Beyaz are similar to other drospirenone-based contraceptives such as Yasmin and Yaz. And critics are united in their quest to rid the market of drospirenone-based birth control products such as Beyaz birth control.

According to the Sentinel, consumer advocacy group Public Citizen is lobbying to have birth control pills containing drospirenone removed from the market. They can cause “increased blood levels of potassium and (are) no more effective than other oral contraceptives in preventing pregnancy,” Public Citizen says, in placing drospirenone-based contraceptives such as Beyaz birth control on its do-not-use list of products.

For its part, the US Food and Drug Administration (FDA) continues to advocate that the risk for adverse events is outweighed by the benefit associated with pregnancy prevention. And yet the FDA, last year, beefed up warning labels due to the potential increased risk for blood clots.

According to the Sentinel, several large studies, including research funded by the FDA itself, concluded that the risk for Beyaz blood clots and deep vein thrombosis from similar contraceptives containing drospirenone was 1.5 times higher than that of older, more traditional birth control pills.

While Bayer continues to stand behind its product and admits to no wrongdoing, it has nonetheless settled scores of lawsuits worth $1.4 billion so far, with the expectation of more coming through the legal pipeline. And as the FDA has signaled that drugs such as Beyaz drospirenone aren’t going anywhere, research has been inconclusive: some studies suggest an increased risk of blood clot, while others have not. And doctors come down on both sides of the fence.

Still, critics of Beyaz birth control and other contraceptives in the drospirenone family continue to rail against them. The class of drugs “shouldn’t be on the market because there are so many safer alternatives,” said Diana Zuckerman, president of the National Research Center for Women & Families. “We can debate how unsafe it is and for whom - more research could obviously clarify that - but there’s really no doubt that it’s not as safe as dozens of other birth control pills.”

Maggie Yunker acknowledges all medication has risks, “but when you’re 20, you don’t think about it.

“I didn’t think anything bad could happen, especially since a doctor was giving it to me,” Yunker said. She sued Bayer and received $237,000 in compensation for her health problems stemming from the drospirenone-based birth control pill she used - which was essentially Beyaz birth control, without the folate. The formulation for Yaz and Beyaz are exactly the same, with the exception of the added folate. And it appears Beyaz birth control often flies under the radar because an insufficient number of women value the addition of folate v. the mitigation of acne, bloating and weight gain promised by Yaz.

But they’re all inter-related. And Beyaz lawsuits continue to percolate quietly, while its bigger brothers Yaz and Yasmin take the heat.