Yaz Side Effects May Cause Blood Clots, Heart Attacks, Strokes

If you’re using an oral contraceptive drug called Yaz® or Yasmin® (generic, Ocella), you should know that these drugs have been linked to serious life-threatening injuries and even death.

Injuries include the following:

    • Blood Clots
    • Strokes
    • Heart Attacks
    • Pulmonary Embolisms
    • Deep Vein Thrombosis
    • Kidney Failure
    • Gallbladder Removal
    • Pancreatic Cancer

Less serious side effects of both Yaz and Yasmin reported to the FDA include the following:

    • Severe Allergic Reactions
    • Rashes
    • Hives
    • Difficulty Breathing
    • Chest Tightening
    • Fainting
    • Severe Vaginal Bleeding
    • Tiredness or Weakness
    • Vaginal Irritation or Discharge
    • Changes in Vision

In 2001, the Bayer Healthcare drug Yasmin was approved for use in the U.S. version. In 2006, Yaz, also marketed by Bayer Healthcare was approved in 2006. The generic version of Yasmin, Ocella, has been marketed in the U.S. since 2008 by Teva Pharmaceuticals. Both Yaz and Yasmin contain the hormones estrogen and progestin, which most birth control pills also contain. Yasmin contains 30 mcg of the estrogen component, ethinyl estradiol, while Yaz contains a lower dose of 20 mcg.

Unlike other birth control pills, Yaz and Yasmin contain a new type of the hormone progestin, known as drospirenone, which until 2001, was never marketed in the United States. Drospirenone can increase potassium levels in the blood stream, which may result in a condition known as hyperkalemia. This condition can disrupt heart rhythms and cause blood clots. An overabundance of potassium can also be dangerous to obese women, diabetic women or women with high blood pressure.

In 2003, the FDA warned the previous manufacturer of Yaz and Yasmin, Berlex Laboratories, to cease airing its television campaign and production of related promotional materials because they were misleading.

According to the FDA,”The TV ad misleadingly overstates the efficacy and safety of Yasmin by suggesting that Yasmin is unique and therefore clinically superior to other birth control pills because it contains the chemically different progestin drospirenone. The unifying theme of the ad, typified by the tagline “Ask about Yasmin, and the difference a little chemistry can make” (emphasis added by FDA) suggests that Yasmin is better than other birth control pills because of drospirenone and the way in which it is metabolized in the body. This “chemistry” difference is presented as a product benefit. FDA is not aware of substantial evidence or substantial clinical experience demonstrating that Yasmin is superior to other COCs or that the drospirenone in Yasmin is clinically beneficial. On the contrary, FDA is aware of the added clinical risks associated with drospirenone…”

Bayer Healthcare, who bought Berlex Laboratories and now manufactuers Yasmin and Yaz, ignored this warning and continued to run misleading television ads. Their efforts did not go unnoticed by the FDA, which said in its letter to Bayer,

“There are numerous warnings associated with the use of Yaz including, but not limited to, venous and arterial thrombotic and thromboembolic events (such as myocardial infarction, thromboembolism, stroke), hepatic neoplasia, gallbladder disease, and hypertension. Moreover, Yaz has additional risks because it contains the progestin, drospirenone. Drospirenone has antimineralocorticoid properties which can lead to hyperkalemia in high risk patients, which may result in potentially serious heart and health problems. Women taking Yaz must be concerned about the drug interactions that could increase potassium, in addition to the drug interactions common to all combination oral contraceptives…The overall effect of the distracting visuals, graphics, concurrent supers and background music is to undermine the communication of important risk information, minimizing these risks and misleadingly suggesting that Yaz is safer than has been demonstrated by substantial evidence or substantial clinical experience.”

Bayer corrected their Yaz campaign in January 2009. However, by that time, Yaz was already one of the most popular birth control pills in the country, with sales of $616 million. Because Bayer downplayed the serious side effects of Yaz, countless young women only heard the benefits of Yaz and as a result, became seriously injured. In fact, in the summer of 2009, numerous lawsuits were filed by women claiming injuries from Yaz. It is anticipated that several more lawsuits will ensue in the future.

We are no longer evaluating these cases.