Popular Contraceptives Under Investigation

Misleading Advertising Brings Lawsuits and FDA Warnings

Oct 15, 2009

Yaz® and Yasmin® are popular contraceptive drugs manufactured by Bayer HealthCare. Yaz® is the top-selling birth control pill in the U.S.

Both drugs have been scrutinized by the Food and Drug Administration (FDA) for a variety of issues. Earlier this year the FDA asked Bayer to correct its television marketing campaign which it deemed to be misleading. In September, the FDA issued another warning about quality control issues at a manufacturing plant in Germany.

Consumer Lawsuits

Bayer acknowledges that it has been served with 74 lawsuits brought by women who have taken either Yaz® or Yasmin® and have developed serious health conditions such as blood clots, heart attacks, strokes, and other health conditions. Anyone who has taken Yaz® or Yasmin® and suffered side effects should consult with a physicuan immediately and consider contacting a Yaz lawyer to determine their rights.

The misleading television campaign involved among other issues, Bayer making claims that Yaz® was effective in treating PMS (premenstrual syndrome) for which the drug has not been approved. It has only been approved for contraception, treatment of a less common condition called PMDD (premenstrual dysphoric disorder) and the treatment of acne. The FDA also warned Bayer about overstating the efficacy of these drugs and minimizing side effects and serious risks associated with taking birth control medications.

History of Risks

Birth control pills have long been considered a risk for blood clots particularly in the legs and lungs, and a risk for stroke. These medications work by altering the woman’s hormone levels to prevent pregnancy. Researchers have long known that drugs containing estrogen increase the risk for blood clots and stroke due to estrogen’s role in blood coagulation. The issue in this case comes from minimizing the risk and potentially increasing women’s risks by misleading them.

Since the 1960s, when contraceptive medications were introduced, drug companies have worked to lower the estrogen levels and help lower the risks of blood clots. However, combination drugs that also use progestin, such as Yaz® and Yasmin®, have been the focus of recent studies because of the possible cardiovascular risks that may be the result of progestin.

Conflicting Studies

Some European studies have also indicated that progestin may cause venous blood clots in some women as well. However, a large-scale study in Europe which was sponsored by Bayer came to different conclusions.

Yaz® and Yasmin® use a form of progestin known as drospirenone which has been shown to increase potassium levels in the body. This may put women who have kidney or liver disease and use these medications at risk for serious heart problems.

Change Advertising Campaign

The FDA has forced Bayer to change its advertising to alert women to the potential risk involving potassium and to the fact that the drugs are not approved to treat PMS. The packaging contains warnings about possible blood clots and strokes. However, plaintiffs' lawyers will argue that Bayer did not do enough to warn women about the possible side effects and that their advertising enticed women to use Yaz® or Yasmin® for off-label uses and was misleading because it minimized the side effects and played up the role of treating acne.

In September, 2009, the FDA cited Bayer for not following proper quality control protocol in calculating ingredients at one of its manufacturing plants in Germany, which provides many of the hormones used in manufacturing these drugs for U.S. consumption. The lawyers will most likely use this FDA warning to demonstrate that Bayer has not taken the safety of their products seriously enough.

Social Responsibility

Before taking any medication, patients should have a clear indication of the risks involved. Drug manufacturers have a responsibility to the the public and their shareholders to provide correct information.

Singer, Natasha. "Health Concerns Over Popular Contraceptives." New York Times September 26, 2009: B1

Side effects of Yaz/Yasmin (http://www.consumerinjurylawyers.com/yasmin/side-effects.html)

The copyright of the article Popular Contraceptives Under Investigation in Public Healthcare Issues is owned by Kathy Quan . Permission to republish Popular Contraceptives Under Investigation in print or online must be granted by the author in writing.