Beyaz Side Effects

Beyaz side effects stem from one controversial ingredient: drospirenone, a new type of synthetic progestin. Drospirenone may increase a woman’s risk of a blood clot by 75%, but it is no more effective at preventing pregnancy. If a blood clot forms in the body, is can break loose, causing a pulmonary embolism, heart attack, stroke, or death.

FDA Updates Beyaz Safety Warnings

April 2012 — The FDA has recently announced that it will be updating the drug safety information for all birth control pills containing drospirenone. In a statement, they said: “The FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The FDA will be updating the drug safety information to warn about the increased risk of blood clots associated with drospirenone.

What is Beyaz?

Beyaz is a once-daily, oral hormonal birth control pill. It is made by Bayer HealthCare Pharmaceuticals, Inc. Beyaz was approved by the U.S. Food and Drug Administration in September of 2010.

Beyaz contains the following active ingredients:

0.02 milligrams ethinyl estradiol, a synthetic form of estrogen
3 milligrams of drospirenone, a new type of synthetic progestin
0.451 milligrams of levomefolate calcium, a metabolite of folic acid

The FDA recommends that women of childbearing age consume at least 0.4-mg of folic acid every day. Deficiencies of folate levels have been associated with severe neural tube defects such as spina bifida, a birth defect that occurs during the first few weeks of pregnancy, before most women are even aware that she is pregnant. Folate also helps build and maintain new cells in a woman’s body.

What is the difference between Beyaz and Yaz?

Beyaz and Yaz contain the same amount of hormones (progestin and estrogen). Both medications have the same side effects. However, Beyaz contains folate, which can help prevent birth defects.

Beyaz and Yaz are both manufactured by Bayer. They are both equally effective at preventing pregnancy. They are also both indicated to reduce symptoms of mild acne and treat symptoms of Premenstrual Dysphoric Disorder (PMDD).

Beyaz and Yaz also both contain drospirenone, a newly-developed “fourth generation” version of progestin, a female reproductive hormone. Drospirenone has recently become a source of controversy.

Beyaz and Drospirenone

The controversy surrounding Beyaz, Yaz, and other “fourth generation” oral contraceptives stems from drospirenone, a new type of synthetic progestin. All contraceptives that contain progestin are known to increase the risk of blood clots. With older generations, the risk was approximately 4-6 per 10,000 women. With drospirenone, this risk increases to approximately 10 per 10,000 women.

Though the increased risk is small, tens of millions of women decided to switch from older types of birth control to newer birth control containing drospirenone, after Bayer ran a $270-million advertising campaign for Yaz and Yasmin in the early 2000s. This advertising campaign was later condemned by the FDA as “misleading” for “failing to communicate any risk information” and falsely claiming Yaz and Yasmin could treat all acne and PMS.

When millions of women switched to drospirenone, the slightly increased risk of blood clots became tens of thousands of cases of blood clots. In 2011, the FDA concluded a study of more than 800,000 women taking drospirenone contraceptive. They determined that women taking drospirenone were 75% more likely to develop a blood clot. In November 2011, an FDA panel voted to update the safety labeling to include information.

Beyaz and Blood Clots

The most severe side effect of Beyaz is death

When you decided to use Beyaz, you may or may not have been aware of the increased risk of blood clots. Some women do not realize that a blood clot is a severe, life-threatening side effect. When a woman is taking Beyaz, she is more likely to develop high potassium levels in the bloodstream. This can contribute to the formation of blood clots deep inside the body, in a condition known as Deep Vein Thrombosis (DVT). These blood clots most often form in the legs, thighs, pelvis, or arms. Because they form deep inside the body, they do not always show symptoms. If one of these blood clots breaks loose, this is called an embolism. The embolism will travel through the bloodstream until it becomes trapped in another blood vessel, commonly in a major internal organ.

If a blood clot forms in the lower body, the heart will pump it into the lungs. The blood vessels in the lungs gradually get narrower, and eventually the blood clot will become trapped. This blocks the supply of blood into this lung tissue, and the tissue begins to die. This is called a pulmonary embolism. Blood clots can also become trapped in the heart, causing a heart attack (myocardial infarction), or in the brain, causing an ischemic stroke.

In the most severe cases, these blood clots lead to death. Bayer is now facing dozens of lawsuits brought by the family members of women who died after using birth control pills containing drospirenone. In total, Bayer now faces more than 11,000 lawsuits brought by women who have suffered severe side effects.