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

Even though thousands of women have suffered severe injuries after taking Yaz and hundreds of lawsuits have already been filed, Bayer Pharmaceuticals is still airing commercials and running full page ads touting Yaz as the #1 most dispensed oral contraceptive in the U.S. with over 26 million prescriptions filled as of December 2009.

The number #1 most dispensed oral contraceptive in the U.S. – 26 million prescriptions – these things mean money, big money. The New York Times reported that the Yaz and Yasmin franchise had worldwide sales of about $1.8 billion in 2008. That same New York Times article has a graph showing the top-selling oral contraceptives between January and June 2009, which includes Yaz, Yasmin and Ocella in the top five. In fact, Bayer itself has a list of its top 20 best-selling products in 2009, and the Yaz and Yasmin products are number one on that list.

But Bayer wasn’t the only one to cash in on the success of these pills. Teva Pharmaceuticals who owns Barr Laboratories which distributes Ocella, the generic version of Yasmin, has made serious profits off this pill. In this press release, Teva said Ocella was launched in July 2008, and sales for that year were $170.2 million. Just this month Teva reported that its sales in North America for the fourth quarter had increased 35% compared with the fourth quarter of last year and that these sales benefited from the launch of the generic version of Yasmin.

So it seems like it’s a pretty simple equation for these pharmaceutical companies: little pill = big profit.

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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.”

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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.

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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.

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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.

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All of the hormones that go into Yaz and Yasmin are manufactured in a laboratory. In that respect, the drugs are no different than any other birth control pill. What makes Yaz and Yasmin so unique is that they contain the hormone drospirenone, or "DRSP."  DRSP, which has never before been used in a birth control pill, is "synthetic." A synthetic hormone is one formulated to be molecularly similar to a hormone found in the human body, but not "bio-identical" to it. 

DRSP was designed to be molecularly similar to the naturally occuring human hormone progesterone. DRSP is no more effective at its job than either progesterone or one of the man-made hormones in other birth control pills that are bio-identical to progesterone. However, DRSP is more dangerous and more frequently causes serious side effects, including clotting.

                         Progesterone                                                 Drospirenone (DRSP)

 

Why would Bayer use a synthetic hormone if it is more dangerous, but no more effective, than an easily manufactured bio-identical hormone? The short answer is money. A drug company can't patent a bio-identical hormone, since is an exact copy of what nature produces. Only a synthetic hormone can be patented. And only with a patent can a drug company protect the market share its advertising campaign wins over.

No synthetic hormone means no patent. No patent means no huge profits.
 

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At this point you probably know that Yaz, Yasmin and Ocella are related birth control pills, but do you know how they’re related? Here’s a little background info we’ve picked up in our research.

Yasmin was originally developed in 2001 by a German pharmaceutical company called Berlex Laboratories. Yasmin was unique in that it contained a new type of hormone known as drospirenone, or “drsp.” The same drsp hormone was used by Berlex again when it developed the birth control Yaz several years later.

Yaz hit the U.S. market in 2006 and shortly thereafter Bayer Healthcare bought Berlex, acquiring the Yaz and Yasmin birth control pills in the process. As reported by Natasha Singer in an article in the New York Times, Bayer marketed Yaz as a different kind of birth control and touted it as effective not only in preventing pregnancy but also as a treatment for PMDD (Premenstrual Dysphoric Disorder) and moderate acne. Bayer advertised Yaz as a way to “Go Beyond Birth Control with Yaz” and promoted the new pill as a quality of life medication.

Yaz and Yasmin are two of Bayer’s best selling medications and, according to Ms Singer's article, the company earned $1.8 billion on the successful positioning of Yaz and Yasmin in the last year alone.

In July 2008, another drug manufacturer, Teva Pharmaceutical Industries Ltd., jumped in on the action when it released a generic version of Yasmin called Ocella, which also contains the drsp hormone.

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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.
 

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