Bayer Birth Control: Commonsense Protection or Cause for Alarm?

Controversy continues to surround Yaz and Yasmin, the most popular contraceptive pills in the country and the top-selling pharmaceuticals for Bayer HealthCare. The Food and Drug Administration recently determined advertising campaigns for the pills to be dangerously misleading because they overstate the drug’s ability to improve acne and other conditions while understating the dangers posed by potential side effects. Quality control issues at a manufacturing plant that produces some of the hormones in the pills also drew the ire of the FDA, which provided Bayer with a warning letter regarding the problems. Most troubling, however, are the allegations presented by lawsuits against Bayer claiming that Yaz and Yasmin increase women’s risks of both strokes and heart attacks.

The outcome of the over 225 lawsuits against Bayer, which have been consolidated and transferred to the U.S. District Court for the Southern District of Illinois, may greatly impact the hundreds of thousands of women who use the drugs. If the drugs are conclusively linked to life-threatening symptoms, women all over America will have reason to be deeply concerned.

Yasmin, Yaz and Ocella

The three birth control pills causing alarm are Yaz and Yasmin, both manufactured by Bayer, and Ocella, the generic version of the Bayer drugs. These drugs all contain a combination of ethinyl estradiol and drospirenone, a unique fourth generation synthetic progestin which is not found in other kinds of birth control.

Studies have shown that drospirenone disturbs the mechanisms that regulate the body’s balance between water and salt. This disturbance potentially raises potassium levels, which in turn increases the risk of clotting and other problems. The drugs have also been linked to heart attack, stroke, pulmonary embolism, deep vein thrombosis, gallbladder disease, cervical cancer, kidney failure and sudden death.

What May Have Gone Wrong?

Oral contraceptives, which have been wildly popular in the United States for decades, work by altering a woman’s natural hormone levels. Certain risks accompany taking any form of oral contraceptive. For example, it is well known that long-term use of birth control pills increases a woman’s risk for stroke and blood clots, primarily because estrogen, an active ingredient in the pills, can affect blood coagulation. As a result, lower estrogen pills have become increasingly popular since the medication was introduced.

Those filing lawsuits against Bayer are less concerned with the estrogen content of Yaz, Yasmin and Ocella than they are about the drugs’ progestin: drospirenone. While a Bayer-sponsored study on progestins concluded that there is no difference in the risks of taking drospirenone pills as opposed to those that include a second generation progestin that has been widely utilized since the 1970’s, two Danish studies found a higher risk of blood clots in women who consumed the newer progestin.

The FDA is currently reviewing the safety of oral contraceptives and is specifically targeting the risks of blood clots, stroke and death among users. Bayer is also conducting a study aimed at comparing the safety of Yaz with the safety of other oral contraceptives. Plaintiffs in the lawsuits against Bayer allege that the manufacturer knew or should have known of the higher risks associated with their pills.

From 2004 through 2007, the FDA has received more than 50 reports of death attributed to the use of oral contraceptives, many of which are manufactured by Bayer. Bayer insisted in a recent press release that their “oral contraceptives are safe and effective when used according to product labeling.”

Know Your Rights

If you or someone you care about has experienced injurious symptoms that may be related to ingesting Yaz, Ocella or Yasmin, or have questions about the Bayer lawsuits, please contact an experienced personal injury attorney. An experienced attorney can provide you with the information you need to protect your rights.