Yaz is an oral contraceptive developed by Bayer. It is considered a fourth-generation birth control because it includes the fourth version of a synthetic progestin hormone along with synthetic estrogen. As newer birth controls are developed, drug companies try to create new progestin hormones that will make the contraceptive more effective and with fewer side effects.

Bayer brought out Yaz with much anticipation and an aggressive marketing campaign, claiming it could treat other conditions while preventing pregnancy. Unfortunately, some of the side effects of Yaz have proven to be serious and even life-threatening. From heart attacks to strokes, to gallbladder disease, side effects have been too much for some women and Bayer is paying the price in lawsuits and settlements.

Yaz for Contraception

Yaz is a fourth generation birth control that contains ethinyl estradiol, a synthetic estrogen, and drospirenone, a synthetic progestin. Together these hormones prevent pregnancy by preventing ovulation, by making the lining of the uterus inhospitable for the implantation of a fertilized egg, and by limiting sperm from fertilizing an egg.

Drospirenone is the fourth reformulation of one of the main ingredients of birth control pills. Bayer developed it and got U.S. Food and Drug Administration (FDA) approval for Yaz in 2001. The FDA approved it to prevent pregnancy. It also approved Yaz to treat premenstrual dysphoric disorder and moderate to severe acne. It is only approved for these uses in women already interested in using a birth control to prevent pregnancy.

Common Yaz Side Effects

All oral contraceptives come along with some side effects. For most women and for most types of birth control, these side effects are tolerable. Some women may need to try a few different oral contraceptives before finding the one that causes them minimal side effects.

Those that are most commonly reported as occurring with Yaz include menstrual irregularities, headaches, tenderness or pain in the breasts, moodiness, nausea, and vomiting. Headaches caused by Yaz may be severe and some women may even experience migraines. The synthetic hormones in Yaz can affect breast cancer, so women with a history of this type of cancer are not supposed to use it.

Blood Clots and Complications

The most common Yaz side effects are not serious, but there are a few that are less common, but deadly serious. One of the most controversial of these has been the possibility of forming a blood clot. Blood clots typically form in the legs, and if not discovered and treated, can lead to very serious and life-threatening complications. Women who are at risk for blood clots should not take Yaz because of this potential side effect.

Although Yaz has been on the market since 2001, it wasn’t until 2011 that the FDA issued a warning about the risk of blood clots. It had already been known that all oral contraceptives increase the risk of clot formation to some degree, but new information had come to light that the risk with Yaz is even higher. The FDA continued to investigate that risk and came to a final conclusion in 2012.

It was then that the FDA announced that Yaz could increase the risk of developing blood clots by as much as three times compared to other birth control medications. At the time of the announcement the agency also put into effect a requirement that Bayer add a special warning about blood clots to the packaging of Yaz. The FDA did not decide to ban Yaz, but issued the strong warning and recommendation that patients and doctors carefully weigh the risks and benefits before using it.

The reason that blood clotting is taken so seriously is because of the complications. When a blood clot moves through the body, it can end up in the brain where it may cause a stroke, in the heart where it can lead to a heart attack, or in the lungs where it can cause a pulmonary embolism. Any one of these can be deadly.

Hyperkalemia

Another serious potential side effect of Yaz and drospirenone is a condition called hyperkalemia. This is unusually high levels of potassium in the blood. Yaz has been found to be able to cause this condition and it can be life-threatening. Having too much potassium may cause a sudden heart attack because it causes the heart to stop beating.

Hyperkalemia should be treated as an emergency medical situation. Signs that someone is experiencing hyperkalemia include fatigue, heart palpitations, weak muscles, and general malaise. Blood pressure medications, ibuprofen, and diuretics used along with Yaz increase the risk of high potassium levels.

Gallbladder Disease

More recent studies into the potential side effects of drospirenone have found that it may trigger gallbladder disease. One study from Canada found that the risk may be increased by 20 percent for a woman using Yaz as compared to birth control medications with other types of progestin. The cause may be that drospirenone causes cholesterol levels to increase, which in turn can cause calcification in the gallbladder.

Gallbladder disease may include cancer, gallstones, inflammation of the gallbladder, or pancreatitis caused by an inflamed gallbladder. Treatment for this disease typically involves the surgical removal of the gallbladder, which is major surgery that carries risks. Removal of this small organ can also lead to long-term complications.

Bayer Advertising of Yaz, Downplay of Side Effects

Bayer has been heavily criticized for how it marketed Yaz and has faced numerous lawsuits from women who were harmed by the drug. Some lawsuits have even come from the families of women who died from complications of blood clots while on Yaz. Early advertising campaigns for Yaz were aggressive and promoted the drug as safe and effective. These ads also heavily promoted the benefits of Yaz, like treating acne and bloating, but it falsely implied that women could take Yaz just for these conditions. The FDA does not allow Yaz to be prescribed for these conditions alone.

Over $1 billion has been paid out by Bayer to date over the side effects Yaz has caused to thousands of women. Although Yaz has been linked to numerous deaths and consumer groups have called for a recall and ban, the FDA has not made any moves to eliminate Yaz and Bayer has continued to stand by its product’s safety.