With its chic marketing and the catchy name, the Yaz birth control pill was introduced in 2006 and quickly became the most popular and best-selling oral contraceptive in the United States. But as quickly as the drug’s popularity skyrocketed, it plummeted amid concerns that it raises the risk of deadly blood clots more than older contraceptive pills.
Behind the scenes, serious side effects of Yaz were being noted because of a synthetic progestin called drospirenone: heart attack, stroke, gallstones and high cholesterol.
Yaz, considered a “fourth-generation” birth control pill, contains estrogen (in the form of ethinyl estradiol) and drospirenone. The progestin in Yaz is considered fourth generation because it’s the fourth reformulation of synthetic progesterone since the birth control pill was introduced in the 1960s.
Yaz was brought to market amid eye-catching television and magazine advertising featuring stylishly dressed young women and catchy music. The drug was touting as not just a contraceptive but also a cure-all for premenstrual dysphoric disorder, bloating and acne.
Between 2007 and 2010, Yaz maker Bayer HealthCare Pharmaceuticals spent more than $270 million on advertising for the drug – the likes of which had never been seen in the United States. By 2009, the U.S. Food and Drug Administration (FDA) reined in the advertising and forced Bayer to spend $20 million on new ads to correct the off-label Yaz marketing and wild claims.
Yaz Side Effects Can Be Severe and Life Threatening
That was just the beginning of the problems with Yaz. Studies from as early as 2006 showed the serious side effects of Yaz. Women who have coronary artery disease, cerebrovascular disease, uncontrolled hypertension, liver disease, migraine headaches and abnormal uterine bleeding should not take Yaz.
Women who have or have had breast cancer and liver tumors also should not use Yaz. Researchers have shown that drospirenone can stop the body from secreting hormones that regulate the body’s electrolytes and water. This can cause a deadly increase in bodily potassium level.
By 2011, studies also showed that Yaz had an increased risk of blood clots, including the FDA’s study that showed a 74 percent increased risk in Yaz users when compared to other oral contraceptives.While all birth control pills carry a risk of blood clots, or venous thromboembolism, the risk from drospirenone is significantly higher, some studies show. Yaz has also been linked to deep vein thrombosis (DVT), a blood clot that forms in a vein deep in the body, typically the legs. Once a blood clot forms, it can break off and travel to various places in the body, including the brain and lungs.
Yaz and Strokes
When a blood clot fractures from its original location and ends up near the brain, the clot can limit or cut off blood flow to the brain. The resulting stroke can leave patients in a vegetative state or dead.
An FDA study estimated that 10 in 10,000 women taking Yaz would get a blood clot a year. A Danish study that looked at women ages 15 to 49 found that drospirenone doubled and tripled the risk of developing blood clots. It is already well documented that estrogen found in all forms of birth control pills increases blood clot risks.
Yaz Pulmonary Embolism
That same blood clot could instead travel to the lungs and block the pulmonary arteries, causing pulmonary embolism. When this happens, the circulation and blood oxygen levels are restricted. This makes it difficult for your lungs to provide oxygen to your body. Again, the results can be debilitating or deadly.
In the Yaz drug insert, the manufacturer warns those who have deep vein thrombosis or pulmonary embolisms, now or in the past, to not take the pill. The risk is greatest in the first year of taking the drug but also continues throughout treatment with the pill, the insert said.
Yaz Heart Attack
Yaz is also linked to heart attacks. Not only does the blood clotting risk increase the chances of a heart attack from Yaz, but also the drug’s link to dangerously high potassium, called hyperkalemia.
Medical professionals consider hyperkalemia an extreme emergency because it can cause the heart to stop suddenly. The symptoms are fairly nonspecific, including muscle weakness, malaise and heart palpitations. Because of these risks, Yaz should not be taken if you have kidney failure, one kidney, liver disease, adrenal disease or a history of blood clots.
Also, some drugs, such as ibuprofen, high blood pressure medicine and certain diuretics, can have serious interactions with Yaz and cause hyperkalemia.
Yaz Gallbladder Disease
This birth control pill has also been linked to Yaz gallbladder disease. The gallbladder helps in the digestive process and concentrates bile produced in the liver. Yaz causes gallbladder disease because it increases cholesterol levels in bile and decreases gallbladder movement. Because of this, gallstones, which are calcified cholesterol chunks, form and the gallbladder becomes inflamed. Even though this disease is not normally fatal, treatment entails a painful and costly surgery.
With all the research pointing to Yaz side effects causing medical problems and death, the FDA has yet to issue a Yaz recall. The drug has been linked to 50 deaths in women as young as 17 and hundreds of injuries. Instead, U.S. drug regulators have become embroiled in controversy in determining the drug’s fate.
In December 2011, the FDA impaneled an advisory board to review the Yaz medical risks. The group voted 15 to 11 that the benefits of Yaz outweighed the risks. In January, a watchdog group, Project on Governmental Oversight, demanded that the FDA take a second look at its advisory committee, claiming at least four members had financial ties to Bayer.
FREE Yaz/Yasmin Case Review
If you had a heart attack, stroke or pulmonary embolism after taking Yaz or Yasmin, you should know your legal options.
Already more than 11,000 people have filed Yaz lawsuits against Bayer, claiming the drug maker mislead women about the health risks of Yaz, among other things. The lawsuits were consolidated into a multidistrict litigation (MDL) in the U.S. District Court in Illinois.
The he first of those trials was supposed to start in January 2012, but the judge instead ordered mediation. A number of cases have also been consolidated in a Pennsylvania state court. The judge in these cases also ordered mediation.
In March 2012, Bayer agreed to settle 70 of the lawsuits for an undisclosed amount. Bellwether trials, which are used to determine future trends in specific litigation, are scheduled for June 2012 if more settlement agreements can’t be met.