Yaz is a type of birth control medication that contains drospirenone and ethinyl estradiol. It is made by Bayer and can be used as birth control while also treating acne and premenstrual dysphoric disorder and an irregular cycle. The main ingredients in Yaz include a synthetic estrogen, similar to what is used in other birth control pills, and a newer type of synthetic progesterone, called drospirenone.

Like older types of birth control, Yaz can cause any number of moderate to mild side effects, but it can also cause serious and debilitating, even life-threatening side effects. These include harmful blood clots, bleeding, kidney damage and migraines. Because of these, and the devastating consequences they have had on women, many lawsuits have been filed against Bayer.

What is Yaz?

Yaz is a contraception or birth control pill that women take to prevent pregnancy. The basic recipe for a birth control pill has been around for decades, but one of the main ingredients in Yaz, drospirenone, is considered a fourth-generation version of one of the important synthetic hormones needed for preventing pregnancy. It is the product of the fourth time this hormone has been reformulated.

Bayer, the German drug company, developed and marketed Yaz, which was first approved for birth control use by the U.S. Food and Drug Administration (FDA) in 2001. Yaz is approved for and indicated for preventing pregnancy. It is also indicated for treating moderate acne and premenstrual dysphoric disorder, but only in those women who also plan to use Yaz as a birth control. Another form of the same basic mediation, called Beyaz, is also indicated for supplementation with folic acid, a nutrient important in preventing birth defects, in women using it for birth control.

When Yaz came out in the early 2000s it was heavily marketed by Bayer and promoted as a new and effective birth control. The marketing scheme worked and it quickly became the most popular oral contraceptive in the U.S.

How it Works

Like other oral contraceptives, Yaz prevents pregnancy by preventing ovulation, the release of an egg from the ovary. Without an egg, pregnancy is impossible. Yaz, again like most birth control pills, contains two synthetic versions of the hormones estrogen and progestin. Synthetic estrogen, ethinyl estradiol in Yaz, prevents the pituitary gland from releasing the hormones that stimulate monthly ovulation.

Synthetic progestin, drospirenone in Yaz, also stops the pituitary gland from releasing the hormones needed for ovulation. It also makes the lining of the uterus inhospitable to a fertilized egg and triggers conditions that limit the ability of sperm to fertilize an egg. It is possible to use only synthetic progestin in an oral contraceptive, but it is not as effective at protecting pregnancy and it causes bleeding between periods.

Common Side Effects

The most common side effects of Yaz include headaches, irregularities in the menstrual cycle, vomiting, nausea, breast tenderness and pain, and moodiness. In women who also use Yaz to treat premenstrual dysphoric disorder, side effects that are most common include the same as those above as well as irritability, weight gain, and decreased libido.

Yaz is not indicated for use in women who are pregnant, who have liver disease or liver cancer, who have breast cancer, or another type of cancer that is affected by estrogen or progestin, who are at risk of developing blood clots, who have abnormal uterine bleeding, or who have kidney damage or impaired adrenal gland function.

Blood Clots

Since Yaz first came out and became the best-selling oral contraceptive, it has taken a major hit in popularity. This is due to the number of serious potential side effects that have harmed and even killed women taking the medication. The more common side effects are typical of birth control, but most oral contraceptives do not put women at risk of having the kinds of serious health problems that Yaz does.

One of the most troubling and devastating of these is the formation of blood clots. It was not until 2011, after the drug had been in use for years that the FDA issued a warning about this risk. The May announcement stated that the organization was reviewing new information about the risk of blood clots. It also stated that all birth control pills include a slightly increased risk of blood clot formation, but evidence had come to light that the risk is greater for those that contain drospirenone.

Later in 2011, the FDA made another announcement that it had not yet reached a conclusion about drospirenone, but that it remained concerned about blood clots. Preliminary results from a study funded by the FDA had found an increase in risk of 1.5 times when compared to women not using drospirenone birth control. A final answer came from the FDA in 2012, which included an addition to labelling for the drug with a warning that some studies found an increased risk of up to three times with use of drospirenone. The FDA decided not to pull Yaz, but suggested that patients and doctors should carefully weight risks and benefits before using it.

For certain women the risks may outweigh the benefits. The risk of developing clots while on Yaz increases for women who smoke, have had blood clots in the past, have heart disease, have high blood pressure, have diabetes, or have severe migraines and are over the age of 35.

Consequences of Blood Clots

The issue of blood clot risks with Yaz is a serious issue that required consideration because the consequences of clots can be deadly. Blood clots forming anywhere in the body can travel to the lungs, heart, or brain and cause severe disabilities or death. In the lungs a clot may cause a pulmonary embolism, which restricts breathing and ultimately oxygen to the brain. In the heart a clot can easily lead to a heart attack, and in the brain it may cause a stroke.

Hyperkalemia

Blood clots are among the most serious of potential side effects of Yaz, but this is not the only concern. Yaz has been shown to cause something called hyperkalemia, an abnormally high amount of potassium in the body. Hyperkalemia can trigger the heart to stop beating suddenly, which is fatal if not treated as an emergency. General symptoms of hyperkalemia include fatigue, malaise, heart palpitations, and muscle weakness. The risk of developing it is greater if a woman is also taking ibuprofen, diuretics, or blood pressure medicine.

Other Serious Side Effects

Yaz comes with many other potential side effects, which can be serious for some patients. For instance, jaundice may develop, which indicates that the drug is not being metabolized well in the liver. Headaches, worsening headaches, and even severe migraines are possible. Studies have shown there is a slightly increased risk for women to develop gallbladder disease while on Yaz. Finally, Yaz may even decrease tolerance to glucose, which can be problematic for women with diabetes or prediabetes.

Lawsuits

Thousands of lawsuits have been filed against Bayer since Yaz first came on the market, most related to the devastating effects of unexpected blood clots. Bayer has been accused of falsely advertising a drug as effective and safe. Early advertisements for Yaz pushed the fact that it could treat PMS symptoms, acne, and bloating and downplayed any risks. Although not admitting to any wrongdoing, Bayer did settle and pay $20 million for corrective ads.

To date, Bayer has spent over $1 billion settling independent lawsuits with individuals who were harmed by using Yaz or family members who lost a loved one to a blood clot when taking the drug. Bayer has continued to stand by its product and the FDA, while issuing warnings, has not pulled it from the marketplace. Just how many more lawsuits will be started and whether this risky drug will ever be pulled, remains to be seen.