Yaz is a prescription birth control pill containing ethinyl estradiol and drospirenone, which was first approved by the U.S. Food and Drug Administration (FDA) in March 2006. In the same year, Yaz received FDA approval for use to treat premenstrual dysphoric disorder (PMDD) a severe type of premenstrual syndrome (PMS). In 2007, Yaz received additional approval to treat acne vulgaris, the most common form of acne that primarily occurs from puberty through young adulthood.
Yaz has been one of the best-selling birth control pills in the United States. While Yaz has helped many women to prevent pregnancy and improve symptoms during menstrual cycles, one of its ingredient, drospirenone, has also caused side effects such as migraines, kidney disorders, and uterine bleeding along with increasing the risk for dangerous blood clots. Because of these injuries, Yaz’s manufacturer, Bayer Pharmaceuticals has faced thousands of lawsuits filed by users of Yaz and related birth control products, Yasmin and Yasminelle.
What Is Yaz?
Yaz is the name brand for a popular birth control pill which contains the synthetic estrogen, ethinyl estradiol and synthetic progesterone, drospirenone. Yaz is manufactured by Bayer Pharmaceuticals which also manufactures sister-drugs Yasmin and Yasminelle, also containing ethinyl estradiol and drospirenone in different amounts. Another member of the franchise, Beyaz also contained a synthetic form of folic acid, but has been discontinued.
Yaz and sister drugs, use drospirenone rather than more common progesterone components. Drospirenone, has a close chemical resemblance to spironolactone, a diuretic, which may be responsible for a number of Yaz’s unique side effects, particularly those affecting the kidneys.
Over the course of a month, Yaz also provides patients with an increased hormone dose in comparison to other birth control pills. A month of Yaz treatment includes 24 active and four inactive pills. Most other monthly birth control regimens provide 21 active and seven inactive pills.
Yaz Side Effects
Like any birth control pill, Yaz users may experience minor side effects that do not pose significant health dangers. These side effects most commonly include changes in menstrual and non-menstrual bleeding.
Common Yaz side effects can include:
- Migraine headaches
- Unusual vaginal discharge
- Vaginal yeast infections
- Stomach cramps
- Changes in weight
- Decreased sex drive
- Problems with tolerating contact lenses
Severe Yaz Side Effects
Though most side effects of Yaz are mild to moderate and will go away with time, others are more severe, may be serious or even life-threatening.
Research has shown that those who take drospirenone birth control pills such as Yaz have an increased risk of developing dangerous blood clots. The risk may be increased by six to seven times when compared to women who do not take any birth control. Compared to women who take levonorgestrel, another type of progesterone, birth control, the risk of blood clots is still doubled.
Likely due to the chemical structure of drospirenone, Yaz also interferes with the body’s natural potassium levels and may increase potassium amounts retained in the body, leading to hyperkalemia. Excessive potassium levels or hyperkalemia can cause serious injury or death. Patients with renal or hepatic issues should not use Yaz because of its effect on potassium excretion and kidney function. Women who begin a Yaz regimen should monitor potassium levels. Patients taking other potassium-increasing drugs are advised not to take Yaz.
Using Yaz may also cause:
- Liver tumors
- Disturbances in liver function
- Gallbladder complications
- Hypertension, or high blood pressure
- Deep vein thrombosis
- Pulmonary embolism
- Inflammatory bowel disease
- Glucose level changes that can cause diabetes or affect lupus
- Anaphylactic reactions, such as hives, itching, breathing difficulty, and swelling of the lips, face, or tongue
One possible concern for Yaz is the way in which the contraceptive adjusts a woman’s cycle. A month’s supply of the average oral contraceptive includes 21 active pills, with seven that are inactive. This aligns fairly well with a woman’s natural cycle. A month supply of Yaz includes 24 active pills, with four inactive. One of the marketing gimmicks for the contraceptive was “shorter periods,” but this came with a level of hormone supplementation that was higher than normal birth control pills and may not be considered “natural”.
Yaz Blood Clots
Yaz contains synthetic estrogen like other oral contraceptives, but it also contains a newer synthetic form of progesterone, or progestin, known as drospirenone. Research shows this ingredient increases the risk for blood clots more than any other type of synthetic progestin.
Deep vein thrombosis (DVT) is a Yaz side effect that occurs when blood clots form in deep veins, such as veins in the leg. DVT which breaks loose, may cause venous thromboembolism (VTE) and may travel through the body to lodge in other tissues. When a clot lodges and blocks off blood flow to a certain area, it may result in cellular death in the lungs (pulmonary embolism), brain (stroke or cerebrovascular accident) or heart (heart attack or myocardial infarction). Any of these Yaz-related blood clot events may be serious, life-threatening or result in death.
Blood clot formation related to Yaz may result in:
- Deep Vein Thrombosis (DVT)
- Venous Thromboembolism (VTE)
- Pulmonary Embolism (PE)
- Cardiovascular Accident (CVA) or Stroke
- Myocardial Infarction (MI) or Heart Attack
Yaz birth control and its associated products including Yasmin, and Yasminelle, along with generic brands Ocella, and Gianvi, were marketed as oral contraceptives ideal for young women. Unfortunately, many consumers who chose to use Yaz found the risks were far greater than indicated by the manufacturer. One of the most serious health concerns associated with the pill was blood clots.
The FDA issued a warning in 2011 stating that Yaz and other drospirenone contraceptives may increase the risk of blood clots by 74 percent when compared to other birth control pills which do not contain drospirenone. Other research has shown that when compared to patients not taking birth control pills, Yaz may increase the risk of blood clots by six or seven times.
Yaz High Potassium Levels
Yaz side effects also include increased potassium levels in the body due to drospirenone effects on hormones which affect sodium and water balance normally regulated by the kidneys. This can cause hyperkalemia, or excessive blood potassium levels. Because heart rhythm is affected by potassium levels in the bloodstream, a significant potassium increase can lead to sudden cardiac death. Increased potassium levels may also result in changes in muscle and nerve function and may result in kidney damage.
Additionally, Yaz may have been covertly marketed as a means of alleviating water weight gain because it has a slight diuretic effect. This component may also play a role in the dangers of the drug due to changes in potassium levels and kidney function. As Yaz is approved and has been actively promoted to treat premenstrual dysphoric disorder and acne vulgaris, teens and women may be likely to overlook some of the concerns that may be caused by Yaz.
Yaz Gallbladder Disease
Research shows Yaz increases a woman’s risk for developing gallbladder disease by as much as 20%, possibly due to the diuretic effect of drospirenone. The presence of drospirenone also appears to impede bile flow in the gallbladder. Additionally, some studies show Yaz increases cholesterol levels, which can lead to its calcification in the gallbladder.
The gallbladder is an organ that is responsible for storing the bile produced by the liver. Bile is the liquid the body uses in the digestive process.
Gallbladder disease triggers a variety of health issues including:
- Gallstones – occur when bile crystallizes into painful stones
- Gallbladder pancreatitis – occur when gallstones block the pancreas, which triggers inflammation in the pancreas. This can be fatal.
- Gallbladder cancer
Gallbladder disease is a serious condition, and the remedy is usually gallbladder removal surgery (cholecystectomy). Once the gallbladder is removed, people often struggle with digestive problems that can last indefinitely. There is also an elevated risk a person will develop post cholecystectomy, a condition that causes gas, pain, bloating, and vomiting, following gallbladder surgery.
Yaz Risk Factors
According to the Yaz safety warning, the highest risk of blood clots as a Yaz side effect occurs during the patient’s first year of treatment. This high risk occurs when the patient takes Yaz for the first time, as well as if the patient restarts Yaz treatment after not using it for a month or longer.
It is strongly advised that smokers over age 35 do not take Yaz. Tobacco smoking greatly increases the risk of developing Yaz side effects such as blood clots, heart attack, or stroke. The risk of developing these severe Yaz side effects increases with the patient’s age and amount of cigarettes smoked. Patients should be aware of the signs of severe Yaz side effects such as blood clots and stroke.
Patients should seek immediate medical attention if they experience the following Yaz side effects:
- Trouble speaking
- Severe chest pain
- Persistent leg pain
- Sudden and severe shortness of breath
- Jaundice, of yellowing of the skin or eyes
- Numbness or weakness in a leg or arm
- Severe, sudden, and unusual headache
- Sudden onset of partial or complete blindness
These symptoms may indicate a severe adverse event has occurred and should be treated as a medical emergency.
Yaz Lawsuit Information
Multiple government agencies accused Bayer of misleading TV advertisements and marketing. Bayer was accused accused of overstating the efficacy of the drug as Yaz advertisements claimed that it could also be used to treat hormonal issues such as PMS and all forms of acne. The FDA and DDMAC determined this was misleading as Yaz was approved only for moderate forms of acne and premenstrual dysphoric disorder, or PMDD. PMDD is a severe and rarer form of PMS.
Additionally, the FDA noted that Yaz advertisements failed to adequately inform consumers of the risks of treatment. The Yaz commercial featured rapid scene changes and background music. These elements distracted from the part of the commercial that outlined Yaz’s risks and side effects. The FDA required that Bayer discontinue these commercials. Additionally, Bayer was required to stress the risk of blood clots on packaging for Yasmin and Yaz.
To settle these claims, Bayer agreed to spend $20 million for a “corrective” advertising and promotional campaign which would clarify misleading claims.
Thousands of people who took Yaz or one of the other drospirenone products made by Bayer such as Yasmin, Yasminelle or Beyaz, and were injured, filed drug injury lawsuits against Bayer Healthcare. These lawsuits cited injuries including blood clots, pulmonary embolism, gallbladder disease, kidney damage and other injuries.
More than 12,000 Yaz and Yasmin federal lawsuits were settled through multidistrict litigation (MDL) which ended in 2019. The closed litigation group included thousands of heart, gallbladder, and blood clotting injuries and more than 100 deaths which have all been resolved. A number of women also sued in separate state cases in Pennsylvania, New Jersey, and California.
By 2014, Bayer had settled over 8,000 cases for about $1.7 billion and was set to settle another 8,000 or so for an additional $2 billion by November 2018. In total, around 20,000 cases or more were settled, including an estimated 7,200 gallbladder claims and 1,200 stroke and heart attack claims.
Currently, no cases are known to remain as part of group litigation in federal or state courts.
Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.