Yaz – Yaz Side Effects

Yaz is a prescription birth control pill. It was first approved by the U.S. Food and Drug Administration (FDA) in March 2006. Later in 2006, Yaz received FDA approval for use to treat premenstrual dysphoric disorder (PMDD). PMDD is considered to be a severe form of premenstrual syndrome (PMS). In 2007, Yaz received additional FDA-approval to treat acne vulgaris, which is the most common form of acne that primarily occurs from puberty through young adulthood.

Yaz is currently the best-selling birth control pill in the United States. While Yaz helped many women to prevent pregnancy and improve their menstrual cycles, it was also known to cause side effects such as migraines, kidney disorders, and uterine bleeding. There are currently thousands of lawsuits against Yaz manufacturer Bayer HealthCare Pharmaceuticals.

What Is Yaz?

Yaz and its sister drugs Yasmin and Ocella have a different chemical composition than most other birth control pills on the market. In addition to synthetic estrogen like other birth control, they contain drospirenone. Drospirenone is a new synthetic form of the hormone progesterone. It has a close chemical resemblance to spironolactone, which is a diuretic.

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 seven inactive pills.

Minor Yaz Side Effects

Like other birth control pills, 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.

Minor Yaz side effects can include:

  • Acne
  • 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

Research has shown that those who take drospirenone birth control pills such as Yaz have an increased risk of developing dangerous blood clots. In fact, the risk is increased six to seven times compared to women who do not take any birth control. Compared to women who take levonorgestrel birth control, the risk of blood clots is doubled.

Yaz also interferes with the body’s natural potassium levels. For this reason, patients with renal or hepatic issues should not use Yaz. Women who begin a Yaz regimen should monitor potassium levels. Yaz can significantly increase potassium levels, which can lead to hyperkalemia. Patients taking other potassium-increasing drugs are advised not to take Yaz. Excessive potassium levels can cause serious injury or death.

Using Yaz may also cause:

  • Liver tumors
  • Disturbances in liver function
  • Stroke
  • 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

Yaz Blood Clots

The FDA issued a warning in 2011 stating that Yaz and other drospirenone contraceptives increased the risk of blood clots by 74 percent. This statistic is in comparison to older generation birth control pills which do not contain drospirenone. 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 can cause a pulmonary embolism when the blood clot dislodges and travels through the patient’s lungs. This specific Yaz side effect is known as venous thromboembolism. Dislodged blood clots can also cause stroke when they travel to the patient’s brain.

Yaz birth control and its associated products including Yasmin, 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.

What are Blood Clots?

Though individual blood clots might develop without a person ever realizing it, clots can travel within the body and settle in dangerous places. When clots form within deep veins of the body the condition is called deep vein thrombosis. This can be a common health condition for older, sedentary adults, but many women who took Yaz birth control also developed deep vein thrombosis. These types of clots are far more likely to move throughout the body and pose danger.

Once a blood clot is on the move, it can interfere with a variety of the body’s vital functions. If a blood clot reaches the brain, it can impede blood flow and cause stroke. If a clot moves to the heart, it can trigger a blockage that causes a heart attack. Blood clots in the lung cause pulmonary embolism, preventing sufficient levels of oxygen from reaching the body.

Link between Yaz and Blood Clots

Studies have shown Yaz increases the likelihood of the formation of blood clots. Originally, Yaz was marketed as an option for young women because the product offered benefits not seen in other types of birth control. Yaz contains synthetic estrogen like other oral contraceptives, but it also contains a new 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.

One of the criticisms of 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 far from natural.

Additionally, Yaz was marketed as a means of alleviating water weight gain because it was a diuretic. Some believe this component also played a role in the dangers of the drug. There were also claims that Yaz could combat other symptoms related to premenstrual disorder and acne.

Lawsuits Mount in Response to Blood Clots Triggered by Yaz Use

In 2011, the FDA began investigating concerns over Yaz. A year passed before a more detailed warning label was applied to the drug. The label cited information from several different studies, two of which were funded by Bayer Healthcare and refuted the evidence found in other studies.

Currently, the approximately 12,000 lawsuits against Yaz are in multidistrict litigation in the Southern District of Illinois. Plaintiffs claim Bayer Healthcare failed to notify Yaz users of the danger associated with the contraceptive. Bayer is settling some of the cases (about 7,500 so far) and intends to continue paying out on a case by case basis. Some familiar with the cases believe final payments could reach more than $2.5 billion.

If you would like to know more about the dangers associated with using Yaz or any of its associated products, including Yasmin, Ocella, or Gianvi, we can help. Consumers should be informed about their options and understand what they can do to protect their rights if they have been injured as the result of taking oral contraceptives.

Yaz Potassium Levels

Yaz side effects also include increased potassium levels in the body. This can cause hyperkalemia, or excessive blood potassium levels. Yaz can cause hyperkalemia due to drospirenone’s nature of decreasing the body’s hormones that regulate sodium and water. A drastic potassium increase can lead to sudden death. This Yaz side effect occurs because the pumping of the heart relies on steady levels of potassium. Kidney damage is another Yaz side effect that occurs from excessive potassium levels.

Yaz Gallbladder Disease

Oral contraception is the chosen method of birth control for many women. It can be a safe, effective, and convenient way to prevent pregnancy, but because it is an oral medication, there are usually side effects. Depending on the brand of oral contraceptive a woman chooses, side affects can be little more than a nuisance. Many women experience mild mood swings, bloating, and weight gain, but the trade-off is peace of mind concerning pregnancy.

Unfortunately, users have reported the Yaz brand of birth control triggers side effects far worse than those listed above. Yaz hit the market in 2006. It was considered an innovative oral contraceptive because it contained drospirenone, which is a synthetic form of the female sex hormone progesterone, or progestin. Many women chose the Yaz brand because it came with the promise of alleviating excess weight from bloating and easing other premenstrual symptoms. Unfortunately, the benefits might have led to serious medical conditions for many Yaz users.

One such concern is the health of the gallbladder. Research shows Yaz increases a woman’s risk for developing gallbladder disease by 20%.

What is Gallbladder Disease?

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 (cholecysteomy). 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 postcholecystectomy, a condition that causes gas, pain, bloating, and vomiting, following gallbladder surgery.

Link between Yaz and Gallbladder Disease

Research seems to indicate the risk from using Yaz birth control is caused by the synthetic hormones found in the pill. Of particular interest is the diuretic effect of drospirenone. Diuretics tend to cause dehydration, especially if a user is unaware of the problem and does little to counteract the effect. 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.

Lawsuits Mount in Response to Gallbladder Problems Triggered by Yaz Use

The manufacturer of Yaz, Bayer Healthcare, believes the research linking their drug and gallbladder disease is weak. One study utilized the IMS LifeLink Health Plan Claims Database and found a potential link between drospirenone and gallbladder disease. The study included the following statement concerning the data:

“In a large cohort of women using oral contraceptives, we found a small, statistically significant increase in the risk of gallbladder disease associated with desogestrel, drospirenone and norethindrone compared with levonorgestrel. However, the small effect sizes compounded with the possibility of residual biases in this observational study make it unlikely that these differences are clinically significant.”

Though the findings were considered a “statistically significant” increase in risk, Bayer Healthcare references the final line of analysis that states the overall findings were “unlikely… clinically significant” to defend the company’s position.

Despite Bayer Healthcare’s defense of their drug, consumers are still taking action. Lawsuits alleging responsibility for health problems related to Yaz are being filed in both state and federal courts. There is also evidence Yaz might trigger other health problems, including stroke, heart attacks, pulmonary embolism, and blood clots.

Most recently, a federal judge leading multidistrict litigation in Illinois postponed a bellwether trial that was scheduled for the beginning of 2014. Cases in other states have been postponed as well. The judge ordered parties involved to mediation. There are more than 10,000 Yaz gallbladder suits in process, but the courts will first deal with cases involving pulmonary embolism, another risk associated with the drug.

According to recent data issued by Bayer Healthcare, about 8,800 claimants have agreed to resolve claims involving gallbladder injuries.

If you would like to know more about the dangers associated with using Yaz or any of its associated products, including Yasmin, or the generic versions Ocella or Gianvi, we can help. Consumers need information about their options and should understand their rights regarding injury. You might be entitled to compensation if you have suffered gallbladder problems as a result of taking oral contraceptives.

Yaz and Pulmonary Embolism

Oral contraceptives have been linked to a variety of health conditions. One such instance includes deep vein thrombosis and pulmonary embolism. Research and anecdotal evidence link the oral contraceptive sold under the brand name Yaz with a two to three time increase in risk for pulmonary embolism. Furthermore, plaintiffs in the lawsuits filed against Bayer Healthcare, the maker of Yaz, allege the minimal warnings provided by the company relating to the drug did little to communicate the true danger associated with taking it.

What is Pulmonary Embolism?

Pulmonary embolism occurs when a blood clot moves from its point of origin to the lungs. When blood clots form in deep arteries in the body (usually the legs), the clots are likely to break free and move to other parts of the body, including the lungs. This can create a blockage to a coronary artery which can have severe consequences, including heart attack and death.

Several medical studies have linked oral contraceptives with an increased risk of forming blood clots, specifically those related to deep vein thrombosis. The increase in clots leads to an increase in risk for the clots to break free and causing serious damage, including pulmonary embolism.

The symptoms of pulmonary embolism include:

  • Pain when breathing, especially during deep breaths
  • Unexplained shortness of breath or rapid breathing
  • Coughing with presence of blood
  • Increased heart rate

Link between Yaz and Pulmonary Embolism

Research indicates the link between pulmonary embolism and Yaz usage is caused by the synthetic hormone progesterone present in the pills. Progesterone, or progestin, is a female sex hormone and Yaz uses a synthetic version known as drospirenone. Drospirenone has a diuretic effect, which helps to alleviate water weight, but also comes with a variety of negative side effects.

In addition to pulmonary embolism, Yaz usage has also been linked with increased heart attack and gallbladder disease risk. There is also evidence drospirenone increases potassium levels to a dangerous degree.

Bayer Healthcare claims the risk of taking the oral contraceptive is no different than it is with any other type of birth control pill. Studies show this is likely not the case. A 2011 study published in the British Medical Journal indicated there is a six times increased likelihood users of Yaz will experience blood clotting. Researchers acknowledge the presence of estrogen in all birth control pills boosts the risk of clotting, but note that the addition of progestin in Yaz makes this risk much greater.

Lawsuits Mount in Response to Pulmonary Embolism Triggered by Yaz Use

More than 12,000 women have filed lawsuits related to the side effects of Yaz. Bayer Healthcare has already paid more than $1.6 billion in settlements related to Yaz and has earmarked additional money for future settlements.

The most recent data shows Bayer Healthcare has settled more than 7,500 claims as of November 2013 related to deep vein thrombosis and pulmonary embolism. Approximately 5,000 lawsuits throughout the country still remain. Litigation has been consolidated at the federal level to an MDL in Illinois, making it one of the largest MDLs in US history.

The lawsuits claim Bayer Healthcare failed to notify Yaz users of the danger associated with their oral contraceptive use.

In addition to the federal MDL cases, Bayer Healthcare also faces a lawsuit from the State of Kentucky related to fraud in marketing charges. There is an additional class action suit in process in Israel.

If you would like to know more about the dangers associated with using Yaz or any of its associated products, including Yasmin, Ocella, or Gianvi, we can help. Consumers should be informed about their options and understand what they can do to protect their rights if they have been injured as the result of taking oral contraceptives.

Yaz Side Effect 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

Yaz FDA Warnings

Since Yaz launched, it has received multiple FDA warnings and communications. Briefly after Yaz was released, Bayer received a fine for the marketing claims that the drug could cure conditions such as PMDD, acne caused by hormones, and other menstrual conditions.

In 2009, a warning letter was sent to Bayer due to a displeasing routine inspection of its German manufacturing plant. The FDA noted that some of the manufacturing equipment was unclean, and that the final products were not adequately tested before being shipped out to distributors.

Yaz Lawsuits

There are currently more than 10,000 lawsuits against Bayer for the harmful side effects caused by Yaz. Yasmin and Ocella also face a number of lawsuits for similar side effects. In addition to the physical harm caused by Yaz, many lawsuits allege that Bayer implemented deceptive practices when marketing the drug. Plaintiffs feel that some claims for Yaz’s capabilities were exaggerated. Additionally, many feel that the health risks were not adequately communicated to consumers.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA. 

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