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.

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Yaz and Yasmin, manufactured by Bayer Pharmaceuticals, are some of the top selling birth control pills in the United States. But as is often the case with such popular brand name drugs, another pharmaceutical company is trying to cash in on some of the success of these pills. Teva Pharmaceutical Industries, Ltd. signed a licensing agreement with Bayer and released a generic form of Yasmin marketed as “Ocella” in July 2008. In Ocella’s first financial year, Teva reported that U.S. sales were $170.2 million.

Well, it looks like Teva is at it again – this time with Yasmin’s sister birth control Yaz. The Associated Press reported that Teva has now released a generic version of Yaz. Yaz, a slightly lower dose of the same hormones used in Yasmin, had sales in the U.S. of $782 million in 2009. Earlier this year in April, Teva received approval from the FDA to market its generic version of Yaz, which Teva is calling “Gianvi.”

Bayer, however, is not too pleased with Teva’s early release of the generic Yaz. As part of Teva’s earlier agreement with Bayer, Teva was not supposed to launch a generic Yaz pill until July 2011. In response to Teva’s decision, the German drugmaker filed a lawsuit against Teva for patent infringement.

As we wrote in an earlier Yaz blog post, these little pills mean big profits for original manufacturer Bayer and now Teva, with its generic forms of Yaz and Yasmin. Despite hundreds of lawsuits filed by women who have suffered life-changing injuries, Bayer and Teva continue to market and profit from the sale of these pills.

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