Weitz & Luxenberg is no longer accepting new cases concerning Yaz/Yazmin/Ocella. This information is provided for informational purposes only.
FDA orders Bayer to provide stronger warnings of Yaz blood-clot dangers
April 11, 2012 – The maker of Yaz and Yasmin birth-control pills has been ordered by the U.S. Food and Drug Administration to provide packaging labels that more clearly warn unsuspecting consumers of the dangers posed by the contraceptives.
According to the FDA, the new labels will include a discussion of studies showing that Yas/Yasmin takers face a threefold greater risk of potentially fatal blood-clotting than do users of others types of birth-control pills.
Yaz and Yasmin are made by Bayer AG.
Yaz blood clots usually develop in the veins of the lower leg or thigh. If the clot dislodges, it can be carried along by the blood stream to the lungs or heart, and there do potentially catastrophic harm.
Yaz and Yasmin are drospirenone-containing contraceptives. Researchers have learned that roughly one of every 1,000 women who take drospirenone-based birth-control pills develop clotting in the form of a venous thromboembolism. To date, more than 100 Yaz/Yasmin takers have died from clotting, according to reports.
The new warning label being required for Yaz includes the following language:
“Vascular risks: Stop Yaz if a thrombotic event occurs. Stop at least 4 weeks before and through 2 weeks after major surgery. Start no earlier than 4 weeks after delivery, in women who are not breastfeeding. (5.1) COCs containing DRSP may be associated with a higher risk of venous thromboembolism (VTE) than COCs containing levonorgestrel or some other progestins. Before initiating Yaz in a new COC user or a woman who is switching from a contraceptive that does not contain DRSP, consider the risks and benefits of a DRSP-containing COC in light of her risk of a VTE. (5.1)”
Yaz, How it Works and the Dangerous Side Effects
What is Yaz?
Yaz, a birth control medication, can be taken by girls and young women who wish to prevent pregnancy. Yaz “tricks” the body into thinking it is pregnant, which prevents the release of an egg.
The drug is classified as a “combination pill” because it is comprised of a low dose of two synthetic hormones: estrogen and progestin. Estrogen is produced in the ovaries, and is instrumental in reproduction, while Progestin aids in the ovulation process.
How does Yaz Work?
Yaz “tricks” the body into believing it is pregnant and prevents the ovulation process. If ovulation, which is the release of an egg into the fallopian tube, is thwarted, the egg cannot be fertilized and pregnancy cannot occur.
A woman’s cervix is lubricated by mucus, which enables the sperm to travel with greater ease in order to fertilize the egg. Yaz hardens the mucus, thus complicating the process.
When taken appropriately, Yaz is 99% effective at preventing pregnancy.
Other than Contraception, Why Do Some Females Decide to take Yaz?
The primary purpose of Yaz is to prevent pregnancy, but there are other clinically proven benefits.
For most girls and young women, the menstrual cycle (colloquially known as the “time of month”), is not a particularly pleasant experience. Depending on the female, menstrual bleeding typically lasts a few days to a week, and the blood flow is often accompanied by cramps in the stomach and lower back. If a female suffers from excruciatingly painful cramps, her doctor might prescribe Yaz, which alleviates cramps, minimizes blood flow and can correct sporadic menstrual cycles.
When a girl or young woman is either about to start her menstrual cycle, those around her might notice that she is more sensitive than usual (i.e. increased irritability, distress, sadness etc.). Heightened sensitivity at this time is considered normal, so long as it does not seriously impede a female’s ability to function on a day to day basis. If it does, she may be suffering from Premenstrual Dysphoric Disorder (PMDD), and her doctor may suggest Yaz as treatment.
Yaz is also prescribed to girls who have mild to moderate acne.
The Darker Side of Yaz
Like all medications, Yaz has its side effects, which can result in a multitude of health problems from heart attacks to strokes, gallbladder disease to blood clots.
According to the Food and Drug Administration (FDA), “between the first quarter of 2004 and the third quarter of 2008, 50 women and girls who took Yaz in the United States died from medical complications.”(The Bulletin)
What distinguishes Yaz from other birth control pills is the presence of drospirenone, “a type of progestin.” Before Bayer Healthcare launched Yaz’s sister pill Yasmin in 2001 and then Yaz in 2006, pills containing drospirenone were never made available in the United States. This is primarily because drospiernone “causes an increase in potassium levels in the blood, which can result in a condition known as hyperkalemia. Hyperkalemia can cause cardiac problems.
The pain and suffering many girls and young women have experienced as a result of taking Yaz, led to multiple litigations across the country. Anne Marie Eakins, a 34 year old teacher from Ohio, blamed her medical condition on misleading Yaz advertisements, and subsequently filed a lawsuit against Bayer Healthcare.
“Eakins said that the ads for Yaz which promised to help with period symptoms and acne problems, prompted her to request the drug from her doctor. Shortly after starting to take the drug in 2007, she developed blood clots in both lungs and lost partial use of her right lung.” (The Bulletin)
Weitz and Luxenberg Can Provide Legal Help For Yaz Patients
It is nothing short of heartbreaking when a person who is in the prime of life develops ailments such as strokes, blood clots and heart attacks, which typically affect much older generations. If taking Yaz has resulted in health complications for you or a loved one, please contact Weitz and Luxenberg for a free consultation.
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