Are Yaz, Yasmin, and Drospirenone Birth Control Pills Putting Your Health at Risk?

When Bayer launched its new birth control drugs, Yaz and Yasmin, it marketed the pills as fourth generation birth control that would not only prevent pregnancy, but would also clear acne and prevent symptoms associated with premenstrual dysphoric disorder (PMDD), including depression, irritability, and tension. But the findings of two recent studies conducted on the pills suggest that the drugs may double or even triple the risk that a woman will experience a venous thromboembolism event while on the drug.

How Safe is Birth Control?
Birth control pills were first introduced in the United States in the 1960s to prevent unwanted pregnancies, but these first-generation pills greatly increased the risk to women of having a stroke, blood clot, or heart attack due to their high levels of estrogen. When the second-generation birth control pills were introduced in the 1970s, women taking the new drugs experienced fewer blood clots, but suffered from more side effects like acne and weight gain.

By the 1980s, third-generation birth control pills had been introduced, but posed a risk of deep vein thrombosis and pulmonary embolism. Today's fourth-generation pills, like Yaz, introduced onto the market in 2006, and Yasmin, introduced in 2001, were marketed as a safer form of birth control, with some added benefits. These newer pills contain estrogen and Drospirenone, a female sex hormone that has received some sharp criticism for its safety. Other pills that contain Drospirenone include Beyaz, Gianvi, Loryna, Ocella, Safyral, Syeda, and Zarah.

"Beyond Birth Control"

In 2007 and 2008, Bayer ran advertisements for Yaz that more than doubled the sales of the drug. According to IMS Health Data, in 2007, the drug earned the company $262 million. But sales of the drug really skyrocketed in 2008, earning the company $616 million.

Bayer marketed Yaz as a lifestyle oral contraceptive that was "beyond birth control" because of its ability to clear acne and curb symptoms associated with PMDD. Commercials run by Bayer featured young twenty-something women looking not only to prevent pregnancy, but also to enhance their lives during that not-so-pleasant time of the month. These advertisements made it seem like more women suffer from PMDD, but according to the National Institute of Health, only about three to eight percent of menstruating women are affected by the condition. Marketing like this helped the pill become the best-selling oral contraception pill in the United States in 2008.

But in 2009, the Food and Drug Administration (FDA) required Bayer to correct its 2007 and 2008 advertisements by saying that the pill would not cure acne and was not meant for women who were suffering from just premenstrual syndrome (PMS) symptoms. Because Bayer downplayed the risks associated with its popular birth control pill, it ended up spending $20 million on corrective advertisements. The company is now also under a six-year requirement to submit any other advertisements to the FDA before they can be aired.

By the end of last year, sales of Yaz were down to $361 million. As a part of its settlement with the government and 27 states, including Texas, Bayer denied any wrongdoing in running the first Yaz advertisements. However, before requiring Bayer to run the corrective ads, the FDA had sent Bayer warning letters that they were in violation of federal regulations by promoting the drug for unapproved uses.

Severe Side Effects
As more women began to take Yaz, more studies were coming out with findings that oral contraceptives containing Drospirenone put women taking the pill at a greater risk for experiencing venous thromboembolism events, such as deep vein thrombosis (DVT), a condition where a blood clot forms deep within a vein and can travel to the lungs, leading to pulmonary embolism, which can be fatal.

At first, studies showed that women on Yaz were no more prone to serious side effects than women on other birth control pills. Of course, all birth control pills pose a risk of causing blood clots, especially in women who are over 35 and are smokers. But these recent studies have found that the risk of this happening is higher in women taking Drospirenone. The European Medicines Agency recently announced this past May that it would require manufacturers of oral contraceptives containing Drospirenone and ethinyl estradiol to update their product information to include the risk of venous thromboembolism.

The FDA has declined to require manufacturers to update their product labels until it can better determine the meaning behind the results of the two most recent studies. However, the FDA did issue a drug safety communication about Drospirenone to alert patients and healthcare providers about the new information currently under safety review.

Worried about the severe side effects Yaz and other pills like it pose to patients, Public Citizen, a consumer advocacy group, placed Yaz on its "do not use pills" list. Dr. Sidney Wolfe, the director of Public Citizen's Health Research Group, stated that companies like Bayer will continue to sell these dangerous drugs if they will make more money selling them than they will lose in litigation.

What are the serious side effects associated with Yaz, Yasmin, or other fourth generation birth control pills that contain Drospirenone?
The most serious side effects that have been reported with the use of these drugs include:

Heart attack
Stroke
Blood Clots
Venous thromboembolism
Deep vein thrombosis (DVT)
Pulmonary Embolisms
Sudden death

What symptoms should I be looking for if I am currently on one of these medications?

Constant leg pain
Severe chest pain
Sudden shortness of breath
Pain in the upper right abdomen that lasts anywhere from 30 minutes to several hours

What should I do if I am on a birth control that contains Drospirenone?
The FDA recommends that you do the following:

Call your healthcare provider immediately if you develop symptoms related to a blood clot. These include constant leg pain, severe chest pain, and sudden shortness of breath.
You should not stop taking the drug without first getting doctor approval.
If you are worried about the side effects associated with these drugs, talk to your doctor about switching to another birth control.
If you smoke and are over the age of 35, you should not take combination oral contraceptives, which are contraceptives that contain estrogen and progestin, because these can pose an increased risk of contracting serious heart problems.
Report any side effects or problems you have while on the medication to MedWatch.

Yaz Litigation
The FDA does not have a very good system in place to monitor adverse drug reactions. In fact, its Adverse Events Reporting System (AERS) has been criticized because it catches only an estimated 10 percent of all adverse drug reactions that occur in the United States. Lawsuits filed against Bayer for adverse patient reactions to Yaz have alleged that the drug has caused 50 deaths since it hit the market. Deaths linked to Yasmin have increased to 140 in recent years. However, these numbers may be understated because many adverse drug reactions are not reported.

Claims filed against Bayer include the allegation that Bayer did not provide adequate warnings about the health risks associated with taking Yaz, such as blood clots, heart attacks, strokes, gallbladder disease, and sudden death. Other plaintiffs have alleged that Bayer was negligent in its marketing and distribution of Yaz.

The number of lawsuits against Bayer for Yaz/Yasmin-related deaths and injuries is quickly approaching 7,000. The first trial against Bayer is set to start this September.

If you or a loved one took Yaz, Yasmin, or another brand name drug containing Drospirenone, and suffered from a heart attack, stroke, blood clot, gallbladder disease, or venous thromboembolism (including a deep vein thrombosis or pulmonary embolism), you may be entitled to compensation. Call dangerous drug attorney Kay Van Wey at 800-489-5082 today to learn more about your rights as a consumer of these products.

If one of your loved ones died from any of the aforementioned conditons, while taking Yaz, Yasmin, or Drospirenone, contact Kay Van Wey.

Don't hesitate to contact Kay Van Wey at (800)489-5082 for a free, no obligation consultation.

Van Wey Law serves:

The entire state of Texas, including Dallas, Plano, Frisco, McKinney, Fort Worth, Austin, Houston, and San Antonio

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