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Beyaz Benefits Do Not Outweigh the Risks

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Seatltle, WABarbra was prescribed Beyaz when she was 18 years old, as an acne treatment. Sadly, the Beyaz benefits did not outweigh the risks. Imagine your teenage daughter taking a medication that clears up her acne—but then she develops blood clots.

“Shortly after taking Beyaz I had a constant pain in my leg and complained to my family doctor but he didn’t think there was any cause for alarm,” says Barbra (not her real name). “Then I noticed little spider veins in that leg and I always felt tired, lethargic. This went on for months, until I started having circulation issues—my lower leg and foot would go numb. If I worked out or did anything active I would be in severe pain for days.”

Fortunately Barbra stopped taking Beyaz. The pain in her leg continued and she went back to her doctor—she had a blood clot in her leg. If she had continued to take Beyaz, she could have wound up with a pulmonary embolism, or worse.

“Sometimes the pain in my leg made it hard to sleep and I had to give up most physical activities,” says Barbra. “I had to take medications to break up the blood clot and meds for inflammation and I had to wear compression hose every day for a few years.

"Needless to say this medication screwed up my junior year of college. I had to work my Spring break so I could pay for numerous doctor visits. This happened a few years ago and I still have to get tested every few months. I’m fearful of any hidden clots. And to this day my leg still hurts.

“I haven’t taken this up with my doctor, but I found out that Beyaz is just as dangerous as Yaz and Yasmin. I can’t believe this birth control pill is prescribed to treat acne in teens as young as 14 years old, even when studies going back to 2009 clearly state the dangers of Beyaz and similar birth control pills.”

In April 2012 the FDA updated information about the risk of blood clots in women taking birth control pills containing drospirenone. The alert, titled "Drug Information Update - Drug Safety Communication” determined that Beyaz and other birth control pills containing drospirenone (DRSP) may be associated with a higher risk for blood clots than those pills with other progestins, such as levonorgestrel.

As a result, Bayer revised labels on its DRSP-containing birth control pills, including Beyaz. Information was added about various medical studies concerning the increased blood clot risks and its birth control pills.

Recent medical studies are as follows:

2009: Two independent studies found that a woman may be twice as likely to develop a blood clot using DRSP-containing birth control pills compared to women using other forms of birth control

April, 2011: Two additional studies published in the British Medical Journal, found similar results. One study said women who use birth-control pills made with the hormone drospirenone are three times more likely to develop blood clots than those who take an older oral contraceptive. A separate study found a doubling of the risk of clots in women who took drospirenone compared with levonorgestrel.

In response, Bayer said, “Given the already large and robust scientific body of evidence, in Bayer’s opinion these studies do not change the overall assessment about the safety of Bayer’s oral contraceptives…" The research showed “significant flaws” and clots are a rare side effect of using any birth-control pill, according to Bloomberg (4/21/11).

October 2011: The FDA announced the preliminary results of its own study that followed nearly 800,000 women. They found that women have at least a 1.5-fold increased chance of developing a blood clot after using drospirenone-containing birth control, such as Beyaz. The risk of developing blood clots is greatest for women in their first year of taking Beyaz.

November 2011: An Israeli study followed 329,995 women taking a drospirenone-containing contraceptive. They found that the risk of blood clots may be more than 40 percent higher, compared with women who take older non-drospirenone contraceptives.


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