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

Bayer has introduced a new birth control pill, Natazia. Bayer doesn’t claim that Natazia is any more effective than Yaz for preventing birth. And unlike the case with Yaz, Bayer doesn’t claim Natazia is approved to treat PMDD, acne, or any other condition.

If Natazia is no better than Yaz, why is Bayer introducing it?

Interestingly, Natazia doesn’t contain drospirenone, or DRSP. That’s the special ingredient that makes Yaz and Yasmin so unique. We think DRSP may be what’s causing our clients to suffer strokes, pulmonary emboli, and gall bladder disease.  Bayer, on the other hand, continues to insist that DRSP is safe and effective for use in a birth control pill. We want to know why Bayer, if it believes DRSP to be safe and effective, has decided not to use the ingredient in its new pill.  We think the answer might lie in the documents dealing with Natazia's development.

Bayer refuses to turn over the Natazia documents we and the other Yaz plaintiffs' lawyers want. Bayer contends that the documents are irrelevant, since they deal with a drug that shares no ingredients in common with Yaz.  According to Bayer's legal brief (pdf):

Not one plaintiff in these coordinated proceedings has alleged any wrongdoing with respect to Natazia or any injury or loss relating to Natazia – a medicine that shares no active ingredient with Yaz or Yasmin. Discovery requests relating to Natazia are therefore irrelevant and beyond the scope of permissible discovery.

Bayer is missing the point. It is the fact that the new medicine shares no active ingredient with Yaz or Yasmin that makes the documents so interesting.

The judge is expected to decide in the next few weeks whether Bayer has to turn over the documents. 

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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.

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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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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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