Yaz (drospirenone/ethinyl estradiol) is a birth control pill containing the synthetic female sex hormone drospirenone, which has been linked to serious, life-threatening side effects. This prompted the FDA to issue a safety announcement concerning Yaz and the risk of stroke, heart attack, deep vein thrombosis (DVT), and pulmonary embolism (PE).
Do I Have a Yaz Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by blood clots, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
July 2012 — Bayer faces nearly 10,000 lawsuits. This month, 76 lawsuits were filed. Bayer has settled 1,500 Yaz lawsuits and set aside $300 million for these cases. The average Yaz settlement is $214,000. More lawsuits continue to be filed.
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 Yaz?
Yaz is a daily oral contraceptive (commonly referred to as “the pill”) produced by Bayer HealthCare Pharmaceuticals Inc. It received FDA approval in 2001 to prevent pregnancy, for premenstrual dysphoric disorder (PMDD), and also for the treatment of moderate acne. Yaz works by preventing a woman’s ovaries from releasing an egg (ovulation). It also affects the lining of the cervix and uterus, preventing an egg from attaching to the uterine wall. Yaz belongs to the “fourth generation” of birth control medications, including Yasmin, Ocella, Zarah, Gianvi, Loryna, Safyral, and Syeda. All of these contraceptives contain a chemical called drospirenone. Drospirenone is a synthetic form of progestin, a female sex hormone.
FDA Study of Yaz
All birth control pills increase a woman’s risk of blood clots. The safety of birth control pills currently on the market has already been established, but the “fourth generation” of birth control (including Yaz) contains drospirenone, which is the focus of new research. The FDA is concerned about drospirenone because five recent studies have found evidence that women who use drospirenone-containing birth control are significantly more likely to develop blood clots (also known as an embolism) that could be debilitating or deadly.
The FDA was concerned by the following data:
- In 2009, two published studies reported that a woman may be twice as likely to develop embolisms while using birth control that contains drospirenone.
- In 2011, two additional studies published in the British Medical Journal found that a woman using drospirenone-containing birth control may be three times more likely to develop an embolism.
- An Israeli study that followed 329,995 women found the risk of blood clots to be 40% higher for women who take drospirenone-containing birth control medicines instead of other oral contraceptives.
The FDA study of Yaz followed 800,000 women on birth control, including women who were taking Yaz. In October 2011, the FDA issued a safety warning, because preliminary results of the study corroborated the data of previous studies. They FDA found that women who take drospirenone-containing birth control have at least a 1.5-fold greater chance of developing an embolism as compared to women who take other oral contraceptives. The risk is greatest in the first year of taking Yaz.
First Warning Letter: FDA Finds Yaz Ads Misleading
In 2008, the FDA sent the makers of Yaz the first warning letter because the “TV Ads are misleading because they broaden the drug’s indication, overstate the efficacy … and minimize serious risks associated with the use of the drug.”
The FDA was concerned because the commercials implied that Yaz could treat severe acne, including cystic acne, and the common side-effects of Pre-Menstrual Syndrome (PMS). However, the FDA only approved Yaz for the treatment of PMDD (premenstrual dysphoric disorder) and moderate acne. After the makers of Yaz received the first warning letter, they agreed to run a $20 million advertising campaign. However, the FDA continued to find serious, ongoing issues with the advertising campaign misleading women.
Second Warning Letter: FDA Finds Yaz Ads “Fail to Communicate Any Risk Information”
In 2009, the FDA sent the makers of Yaz the second warning letter because the ads are “misleading because they … fail to communicate any risk information associated with the use of these drugs.”
The 2009 ads also failed to communicate the FDA-approved uses of Yaz, which might have corrected the misleading implications from the 2008 advertising campaign.
The FDA did not report how many women may have been misled into falsely believing that Yaz was a safer alternative to other birth control, and subsequently developed a serious complication. Clearly, however, the ongoing issues that began in 2008 were not resolved in 2009. By that time, millions of women were using Yaz.
Yaz Side Effects
One side effect of using Yaz is Deep Vein Thrombosis (DVT). In DVT, blood clots form in the body, most often in the large arteries in the legs. Symptoms of DVT may be swelling, pain in the extremity, slurred speech, or blurred vision. If you experience any of these symptoms while taking Yaz, consult an emergency physician immediately, because you may be at risk of a life-threatening complication. Usually the symptoms of DVT resolve without treatment. However, in rare cases, a blood clot may break loose and travel through the bloodstream. This is called an embolism. If the embolism travels to the lungs, heart, or brain, it may block the supply of blood to these organs. This is called a stroke. If a stroke is not treated quickly, it can be fatal.
- Pulmonary embolism (PE) is when an embolism blocks to supply of blood to the lung. The lack of oxygen can cause permanent injury to the lungs, and may even cause death. If left untreated, 30% of people with a PE will die, usually within the first few hours of the event.
Other side effects:
- Cardiovascular events, especially in women who smoke
- Liver disease
- Uterine bleeding
- Idiopathic Intracranial Hypertension (IIH)
- Pseudotumor Cerebri (PTC)
Do I have a Yaz Lawsuit?
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