Dangerous Side Effects
Yaz has been linked with serious adverse heart problems in women taking the drug. In a reprimanding letter sent to the manufacturer of Yaz, the Food and Drug Administration (FDA) warns of blood clots, heart attack, stroke, and gallbladder disease in Yaz users (1).
The FDA goes on to say, “Yaz has additional risks because it contains the progestin, drospirenone […] 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 (1).”
What Have Yaz Studies Revealed?
The British Medical Journal (BMJ) released a report revealing that blood clots in Yaz and Yasmin are as frequent as with third generation birth control pills. Third generation pills had an established warning for blood clots, but Yaz and Yasmin did not yet have such a warning.
The FDA then released results from a study that included over 800,000 American women who were taking various forms of birth control between 2001 and 2007. The research revealed that women taking Yaz had a 75 percent higher chance of getting a blood clot than women taking older forms of birth control pills.
Elevated Potassium Levels
Yaz also has been linked to a condition known as hyperkalemia. Hyperkalemia is a condition that describes abnormal levels of potassium in the bloodstream, which can lead to fatal arrhythmias. Arrhythmias are disorders of the speed at which the heart beats.
Heart Attack, Stroke, and Blood Clots
Yaz and other oral contraceptives present an increased risk of heart attack in users (2), especially in smokers. In addition to heart attack, there is an established link between oral contraceptives and blood clots and stroke.
Quality Control Issues
U.S. health regulators warned the manufacturer of Yaz about its quality control issues at a plant that makes several of the ingredients in Yaz. The FDA said inspectors found testing problems at the company’s plant in Bergkhamen, Germany. One of the drugs on the list that may not be up to standards is Yaz’s main ingredient, drospirenone (4).
Bloomberg reports that lawsuits have been filed against the manufacturer of Yaz, claiming that Bayer unlawfully promoted the drug by concealing side effects, including blood clots, heart attacks, and pulmonary embolisms in Yaz users.
Furthermore, a Swiss health regulation investigation into the death of a woman who took Yaz and died of a blood clot in her lung is currently underway.
Yaz Marketed for Unapproved Uses
In January 2009, the FDA required the maker of Yaz, which ran commercials claiming Yaz could be used to cure headaches and severe acne (uses that are not approved by the FDA), to launch a campaign correcting those false claims.
The FDA said, “These violations are concerning from a public health perspective because they encourage use of Yaz in circumstances other than those in which the drug has been approved, over-promise the benefits, and minimize the risks associated with Yaz (1).”
Yaz is approved for use as an oral contraceptive, to treat moderate acne in women ages 14 and older, and to help reduce some emotional and physical symptoms of PMDD (a condition in which a woman has severe depression symptoms, irritability, and tension before menstruation). Yaz is not approved to cure PMS, severe acne, or all of PMDD’s symptoms.
Despite the dangers, marketing violations, and manufacturing issues Yaz has been associated with, it is still on the market today.
We Want to Help
If you or someone you care about took Yaz and suffered a blood clot, stroke, or heart attack, someone at our law firm would like to speak with you. We may be able to help.
- “Yaz (drospirenone and ethinyl estradiol) Tablets Warning Letter to Bayer HealthCare,” from the Food and Drug Administration (www.fda.gov).
- “Yaz Prescribing Information,” from the Yaz warning label. Accessed 4/3/09 via www.yaz-us.com.
- “Hormonal contraception and risk of venous thromboembolism: national follow-up study” from theBritish Medicine Journal. Accessed 8/20/09 via www.bmj.com.
- “FDA warns Bayer over German manufacturing plant,” fromThe Associated Press via www.yahoo.com.
Yaz® and Yasmin® are registered trademarks of Bayer Pharmaceuticals. Ocella® is a registered trademark of Barr Laboratories, Inc. Trademarked names are used only to identify the products in question.
This law firm is not associated with, sponsored by, or affiliated with The Associated Press, Barr Laboratories, Inc., Bayer Pharmaceuticals, the British Medicine Journal, the Food and Drug Administration, or Yahoo!