Yaz On Trial : Yaz Birth Control Lawsuit : Info on Yasmin & Ocella Side Effects

The oral contraceptives sold many years ago carried a risk of gallbladder disease. But Yaz, a new low-estrogen birth control pill, promised women a reduced risk. Yet, women on Yaz are reporting gallbladder disease at record rates. 

Gall bladder disease can be painful.  It can cause fever, nausea, and vomiting. Ultimately, if the gallbladder needs to be removed, it can result in life-long digestive trouble. 

There are different types of gallbladder disease. They include:

• Gallstones in the gallbladder (cholelithiasis); 
• Gallstones in the gallbladder's cystic duct or common bile duct (biliary colic);
• Inflammation of the gallbladder (cholecystitis) -- with or without stones;
• Calcification of the gallbladder ("Porcelain gallbladder") --  with or without stone; and
• "Chronic acalculous gallbladder disease" -- A condition where the gallbladder doesn’t move properly. 

Yaz may bring about gall bladder disease by causing stones to form.  Or it may adversely affect the musculature of the gall bladder so that the gallbladder cannot function properly.  As a result, the gallbladder may become inflamed and painful ("chronic acalculous gallbladder disease").

Many of us have gallstones and don't even know it. But 90 percent of the time, they will never cause any trouble. It now appears that Yaz may cause stones that would otherwise be asymptomatic to become painful.  Gallbladder removal may thus be required within months of first taking Yaz.  

Gallbladder removal can usually be performed laparoscopically, which involves removal of the gallbladder through very small incisions in the abdomen using small, specialized instruments, including a camera that allows the surgeon to view the inside of the body on a TV monitor. After gallbladder removal surgery, some women report feeling much better and relieved of their gallbladder disease symptoms. Other women, however, continue to suffer symptoms such as indigestion and abdominal discomfort long after the surgery as a result of having no gallbladder in which to store bile.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

On Friday, March 26, 2010, Bayer announced that it will update the Yasmin label in the European Union (EU). The new Yasmin label will include the results of four epidemiological studies (epidemiological studies are conducted to figure out what factors affect the health and illness of a population).

Two of those studies found that oral contraceptive pills which contain the hormone drospirenone (such as Yaz, Yasmin and Ocella) are associated with a significantly increased risk of venous thromboembolism, a medical term used to describe a blood clot in a vein, which can lead to more serious injuries including pulmonary embolism or stroke. The studies, conducted in Denmark and the Netherlands, were published last year in the British Medical Journal.

After viewing these reports, the Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) (a section of the European Medicines Agency) concluded that users should be informed of this new risk information and became the driving force behind the addition of these two independent studies to the new Yasmin label.

The other two studies to be included on the new label (EURAS and Ingenix studies) were sponsored by Bayer, the maker of Yasmin and Yaz. Unsurprisingly, the Bayer-sponsored studies concluded that the risk of blood clots in Yasmin users is comparable to the risk found for women who use historically safer oral contraceptives which contain the hormone levonorgestrel.

At this point, the Yasmin label change is only due to go into effect in Europe and the exact language for the new label has not yet been revealed.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Potassium – most of us probably know that we can get potassium from eating certain foods like bananas and oranges, but for those of us whose last biology class was more than a few years back, we may forget what potassium actually does in the body. Potassium is mineral that helps the kidneys function normally and it is also an electrolyte. An electrolyte is a substance that conducts electricity in the body, along with sodium, chloride, calcium, and magnesium. Potassium is crucial for your heart to function properly, and maintaining a healthy level of potassium is important to your health.

So how does this relate to Yaz? The Yaz birth control pill, along with Yasmin and Ocella, contains the synthetic progestin known as drospirenone, which can increase potassium levels in the blood. The problem is that increased potassium levels can lead to a potentially dangerous condition known as hyperkalemia. Possible complications from hyperkalemia include:

• Arrhythmias (abnormal heart rhythms)
• Cardiac arrest
• Changes in nerve and muscle (neuromuscular) control

Women with conditions such as kidney, liver or adrenal disease should not take Yaz because it can cause serious heart or health problems, including hyperkalemia. Other medications can also increase potassium levels in the blood, which could be very dangerous if taken in conjunction with Yaz.

As the FDA said in its 2003 Warning Letter to Bayer (the manufacturers of Yasmin), “Women taking Yasmin must be concerned about drug interactions that will increase potassium, in addition to the drug interactions common to all COCs [oral contraceptives]. Therefore, these women and their healthcare providers must weigh Yasmin's additional health risks when considering Yasmin over COCs [oral contraceptives] without drospirenone.”

• Email This
• Print
• Comments
• Trackbacks
• Share Link

There are now over 400 lawsuits pending against the makers of Yaz, and it is anticipated that thousands more will be filed in the future. Behind each of these lawsuits is a story of a woman who suffered a serious injury after taking Yaz, many of whom will be living with the side effects of their injuries for the rest of their lives.

Bayer Pharmaceuticals, the manufacturer of Yaz, would have a hard time denying that California Yaz user Susan Galinis’s life has changed forever. Susan, the mother of twins, suffered a stroke one month after she began taking Yaz. The stroke caused her permanent and severe brain damage, fundamentally changing her life and the lives of her family forever. There is also Katie, a Pennsylvania Yaz user who was just 15 years old when she suffered a pulmonary embolism while taking Yaz. Katie was forced to undergo extensive surgery when doctors found that she had two blood clots, one in each pulmonary artery. Another woman, Ohio Yaz user Anne Marie Eakins also developed blood clots in both lungs after taking Yaz, resulting in her losing partial use of her right lung. Anne, like many of the other women we have spoken with, asked her doctor about Yaz after seeing the commercials. “To be perfectly honest,” she said, “ I asked my doctor about Yaz because I had seen the commercial and it mentioned helping control your period symptoms and acne, which was very attractive to me… I didn’t think it was going to be worse than any other pill.”

Then there are the thousands of women who have suffered gallbladder problems, such as one young woman who at just 22 years old when she began suffering gallbladder attacks while taking Yaz. She, like many Yaz users, was young, healthy and had no prior or family history of gallbladder problems; yet, after taking Yaz, she developed gallbladder attacks so severe that she had to undergo surgery to have her gallbladder removed.

These stories are just glimpses of the impact Yaz has had on women's lives. As more lawsuits are filed and the word spreads, more women’s stories will be heard.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Many of our clients have suffered blood clot injuries after taking Yaz, Yasmin or Ocella. One of the most serious blood clot injuries is “deep vein thrombosis” – also known as “DVT” – which is when a blood clot forms in the veins, usually the legs. If not treated in time, a DVT can lead to other serious health problems such as a pulmonary embolism or a stroke. Part of the controversy surrounding Yaz, Yasmin and Ocella is that recent medical studies have found that the synthetic hormone contained in these birth control pills known as drospirenone is associated with a significantly higher risk of patients developing DVT and other related health problems.

Recently Baltimore’s local NBC news station ran a story about how hospitals and doctors are treating people who have been diagnosed with a DVT or related injuries:

NBC Baltimore (WBAL): Treating Deep Vein Thrombosis

• Email This
• Print
• Comments
• Trackbacks
• Share Link

One of our clients, Susan Galinis, suffered a stroke after taking Yaz, and she is not alone. There are now multiple lawsuits filed by women and their families who suffered strokes after taking the birth control pills Yaz, Yasmin and Ocella.

Although we sometimes hear about strokes in the news, many people don't know what a stroke really is. The vast majority of strokes are ischemic strokes, which occurs when the flow of blood to a part of the brain is interrupted or seriously reduced. This prevents oxygen and necessarily nutrients from getting to the brain causing brain cells to die, leading to a loss of brain function in the affected areas.

This disturbance in blood flow can be caused by obstruction of a blood vessel due to a blood clot. Medical studies have found that the hormone used in Yaz, Yasmin and Ocella known as drospirenone or drsp was associated with a substantially higher risk of venous thrombosis, a medical term for blood clots in the veins.

After having a stroke many women experience life altering side-effects such as loss of mobility and memory, as well as difficulty with speech and communication.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

We've spoken to many women who have developed blood clots after taking Yaz, Yasmin and Ocella. Some of these women have been diagnosed with deep venous thrombosis or DVT, a medical term for blood clots found in the veins and most commonly in the legs. Other women have been diagnosed with a pulmonary embolism which means there is a blood clot or many clots blocking the lungs. Because a pulmonary embolism almost always occurs in conjunction with deep vein thrombosis, some doctors refer to the two conditions together as venous thromboembolism (VTE).

A pulmonary embolism or PE is when there is a blockage of the main arteries of the lungs. A PE can occur when a blood clot travels through the bloodstream and creates a blockage in the pulmonary artery. It's unusual to experience a solitary pulmonary embolism. In most cases, multiple clots are involved. The lung tissue served by each blocked artery is robbed of fuel and can die, which makes it more difficult for your lungs to provide oxygen to the rest of your body.

Immediate symptoms can range from shortness of breath, chest pain and coughing up blood, to collapse and even death. The Mayo Clinic reports that about one-third of people with an undiagnosed and untreated pulmonary embolism don't survive. When the condition is diagnosed and treated promptly, however, that number drops dramatically. Please contact your doctor immediately if you experience unexplained shortness of breath, chest pain or a cough that produces bloody sputum.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Many women are reporting that they developed blood clots after taking Yaz, Yasmin or Ocella. For those of you who may not know what a blood clot is, a blood clot is caused when blood hardens (coagulates) within a blood vessel in the body or in the heart. The problem is that blood clots can become dangerous, even life-threatening, if not treated immediately.

Part of the controversy surrounding Yaz, Yasmin and Ocella is that recent medical studies have found that drospirenone or drsp, the synthetic hormone in these birth control pills, is associated with a significantly higher risk of venous thrombosis (blood clots in the veins).

There are two main types of blood clot complications:

"Thrombosis" involves a clot that forms in a blood vessel and creates a blockage, obstructing the blood flow. A common form of this is known as deep venous thrombosis or DVT, when a blood clot occurs in the veins, usually in the legs.

"Embolism" involves a blood clot that forms in one part of the body, then frees itself and travels through the blood stream until it ends up getting stuck in a blood vessel in another part of the body, such as the lungs, heart, or brain.

Blood clots can cause other life-threatening health complications such as a Pulmonary Embolism or Stroke.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Yaz in the News:

As reported by Bloomberg News, in late September 2009, Swissmedic, the Swiss regulatory authority for drugs and medical devices, began an investigation into Yaz after a woman died from a pulmonary embolism while taking the birth control pill.

On October 22, 2009, Swissmedic released the results of its investigation but, unfortunately for us English-speakers, those findings were only released in German. Bayer was quick to offer their translation and issue a press release stating that “Swissmedic Sees No Higher Risk for Drospirenone Pills.” However, as Jim Edwards of BNET pointed out, upon further examination it isn’t clear that Bayer’s translation is 100% accurate.

From our understanding of the Swissmedic report, the study is still subject to peer review and a final report will be released at a later date with more information about the final results. In the meantime, if you are able to read German, feel free to take a look at the current report and let us know what you think.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link

All birth control pills come with some risk, but what many people don’t know is that there is medical evidence showing that the hormone used in Yaz, Yasmin and Ocella known as drospirenone, or "drsp," substantially increases that risk.

Earlier this year the British Medical Journal published two studies which found that birth controls which contain drsp substantially increase a woman’s risk of blood clots, what doctors refer to as “thrombosis.” One study was conducted in Denmark and the other in the Netherlands.

In addition to these two reports, the British Medical Journal also published a paper about Yasmin. The paper said that it had received reports about women who suffered a “thromboembolism as a suspected adverse drug reaction to the new oral contraceptive Yasmin.”

Why this matters: There is medical evidence showing that the hormone used in Yaz, Yasmin and Ocella can cause blood clots, and blood clots can cause life-threatening health complications such as a stroke or pulmonary embolism. Women and their families need to know the additional risks before taking these drugs.

• Email This
• Print
• Comments
• Trackbacks
• Share Link

Birth control pills, or oral contraceptives, have been around for decades.  But what you may not know is why Yaz, Yasmin and Ocella are different than other birth control pills.

Like many other oral contraceptives, Yaz and Yasmin are called “combination” birth control pills because they contain two types of hormones: estrogen and progestin. Yaz and Yasmin (also known by the generic name Ocella) contain a relatively new type of progestin hormone known as drospirenone, or “drsp” and a type of estrogen called ethinyl estradiol.

The problem is that medical studies have shown that birth controls containing drsp may cause more serious health risks than other birth control pills. In fact, the British Medical Journal recently featured a Dutch medical study and a Danish medical study, both of which concluded that birth control pills containing drsp have a higher risk of causing thrombosis (a fancy medical term for blot clots).  Blood clots can be life-threatening; if a clot travels to the lungs it can cause a pulmonary embolism, while a clot that travels to the brain can lead to a stroke.

Yaz and Yasmin are two of the top-selling birth control pills in the United States, and because they contain drsp, they may put women at greater risk for developing serious health complications. In fact, the FDA has warned that women with high levels of potassium levels shouldn’t take Yaz or Yasmin because drsp may also cause an increase in potassium, which can be life-threatening.

Women should check with their doctors for more information about potential Yasmin, Ocella and Yaz side effects.
 

• Email This
• Print
• Comments
• Trackbacks
• Share Link