Yasmin/Yaz Birth Control

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Yaz birth control and Yasmin Birth Control are oral contraceptives manufactured by Bayer HealthCare Pharmaceuticals, Inc. Lawsuits have been filed against Bayer, alleging serious Yaz side effects and Yasmin side effects. An increased risk of deep vein thrombosis (DVT), pulmonary embolism (PE) and gallbladder problems have reportedly been linked to the use of Yasmin birth control, Ocella and Yaz birth control pills.

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Yaz and Yasmin Lawsuits

On December 8, 2011, the FDA voted 21 to 5 that labeling on Yaz and Yasmin is inadequate and should be updated to include information from several studies that suggest a higher risk of blood clots associated with the birth control. The group voted 15 to 11 that the pills are still beneficial and should remain on the market, although that vote was close, with more than a third of the people on the panel voting against the birth control pills. Some experts voiced a concern that the newer generation of birth control pills, including Yaz and Yasmin, are no more effective than safer alternatives.

In November 2011, Health Canada announced that a review of drospirenone-containing contraceptives found 1.5 to 3.0 times the risk of blood clots. The Canadian health agency said that labels have been strengthened to include a warning about the risk. The agency further recommended that health care professionals weigh the risks and benefits of certain birth control products that contain drospirenone when determining which contraceptives to prescribe.

Bayer Healthcare Pharmaceuticals, the maker of the Yaz and Yasmin branded birth control pills, faces a lawsuit alleging that the products can cause potentially fatal blood clots and/or gallbladder disease. One lawsuit alleges that Yaz caused the plaintiff, a woman of childbearing age, to have a pulmonary embolism.

At the heart of the issue is the new combination of hormones used in Yaz/Yasmin, namely drospirenone and ethinylestradiol, which appear to be associated with a risk for blood clots, in addition to a lengthy list of side effects and contraindications.

The Yasmin lawsuit, filed in the US, states: "In April 2002, the British Medical Journal reported that the Dutch College of General Practitioners recommended that the older second generation birth control pills be prescribed in lieu of Yasmin, as a result of 40 cases of venous thrombosis among women taking Yasmin."

The complaint also states "In February 2003, a paper entitled Thromboembolism Associated with the New Contraceptive Yasmin was published in the British Medical Journal detailing a Netherlands Pharmacovigilance Center report of five additional reports of thromboembolism where Yasmin was suspected as the cause, including two deaths."

Ocella is the generic equivalent of Yasmin birth control pills, and is manufactured by Barr Laboratories. These three birth control pills that contain ethinyl estradiol and the new "fourth generation" progestin drospirenone (DRSP) have been linked to deep vein thrombosis (DVT); Pulmonary embolism (PE); gallbladder complications and gallbladder disease; stroke; heart attack and death.

Yaz and Yasmin Birth Control

The US Food and Drug Administration (FDA) approved Yasmin in 2001 for both birth control and treatment of PMDD (Premenstrual Dysphoric Disorder). Since that time it has become the top-selling birth control pill in the US. However, Bayer, the maker of the Yasmin contraceptive pill, has been reprimanded on several occasions because of questionable advertising campaigns.

In addition to concerns about pulmonary embolism and deep vein thrombosis, Yasmin and Yaz birth control have reportedly been linked to an increased risk of gall bladder problems.

The gallbladder aids in the digestive process and concentrates bile produced in the liver. Because Yasmin/Yaz is a diuretic, this oral contraceptive can cause serious gall bladder problems and gallbladder disease that could potentially require surgery for gallbladder removal.

Symptoms

Symptoms of gallbladder problems could include:

Pain or discomfort in the upper right side of the abdomen
Nausea
Diarrhea
Abdominal Bloating
Jaundice

Symptoms of blood clots could include:

sudden severe headaches
unusual swelling or pain in the legs or arms
sharp or crushing chest pain or coughing blood
eye problems such as blurred or double vision or complete loss of vision
pain in the back of the lower leg

Safyral

Bayer’s Safyral, a new oral contraceptive, was approved by the FDA in December 2010. This birth control pill (drospirenone 3 mg/ ethinyl estradiol 30 mcg/ levomefolate calcium 451 mcg tablets and levomefolate calcium 451 mcg tablets) is designed to raise folate levels for the purpose of reducing the risk of rare neural tube defects (NTDs) in a pregnancy conceived while taking Safyral or shortly after discontinuing it.

Like Yaz and Yasmin (also made by Bayer), Safyral contains drospirenone, known to increase too much potassium in some consumers. And like Yaz and Yasmin, Safyral has been associated with an increase the risk of serious conditions including blood clots, stroke, and heart attack. The risk of blood clots is highest during the first year of use.

Other oral contraceptive brands containing drospirenone include Beyaz and Safyral. Generic versions of Yaz are marketed by Teva (Gianvi) and Sandoz (Loryna). Yasmin generics include Bayer's Ocella, Sandoz's Syeda and Watson Laboratories' Zarah.

Bayer HealthCare Pharmaceuticals has warned that women should not use Safyral if “they have kidney, liver, or adrenal disease because this could cause serious heart and health problems, or if they have or have had blood clots, certain cancers, history of heart attack or stroke, or if they are or may be pregnant. Safyral increases the risk of serious conditions including blood clots, stroke and heart attack. Smoking increases these risks, especially in women over 35. The risk of blood clots is highest during the first year of use.”

Conflicting Birth Control Studies

Recent studies have reached differing conclusions on the risks of newer birth control pills.

A study published in the British Medical Journal October 2011 involving more than 1 million Danish women found that women taking Yaz and other newer medications had twice the risk of blood clots as women taking the older hormone levonorgestrel.

In 2007, however, two studies published as part of the postmarketing requirements of the FDA or European regulators did not find any difference in blood clotting between the two comparable groups. A recent Yasmin FDA-funded study has shown that preliminary results suggest about a 1.5-fold increase in the risk of blood clots for women who use drospirenone-containing birth control pills compared to users of other hormonal contraceptives. The FDA said it hasn't reached a final conclusion on the drugs' safety; instead an advisory committee meeting is scheduled Dec. 8, 2011, to discuss the risks and benefits of birth control pills that contain drospirenone. Here is the complete FDA study.

Yaz, Yasmin and related drospirenone-containing pills were Bayer's second-best-selling franchise in 2010 at $1.6 billion in global sales, according to the Associated Press.

Yasmin and Yaz Time Line

2001: Yasmin birth control is approved by the FDA.

2002: European regulators express concern about link between Yasmin and venous thrombosis after death of 17-year-old. Dutch doctors are advised not to prescribe Yasmin until studies have established its safety.

2003: Maker of Yasmin is warned by the FDA to stop running misleading advertisements regarding Yasmin. The ads allegedly overstate the product's efficacy while understating the health risks.

2006: Yaz birth control is approved by the FDA.

2009: Bayer is forced by the FDA to run ads clearing up alleged misstatements in advertising for Yaz. The FDA alleges that the Yaz ads overstate the drug's ability to cure acne and treat premenstrual syndrome while downplaying the drug's risks.

2009: Lawsuits are filed in the US against Bayer alleging Yaz and Yasmin are associated with an increased risk of heart attacks, blood clots and strokes.

2010: Lawsuits are filed in Canada alleging Yasmin and Yaz are associated with an increased risk of heart attack and strokes.

2011: Yaz bellwether trials get under way. The first Yaz bellwether trial is scheduled to take place September 12, 2011 for pulmonary embolism side effects; that will be followed by one set for January 9, 2012 and finally a Yaz thromboembolic case on April 2, 20121.

Yasmin Birth Control Legal Help

If you or a loved one has suffered an adverse health event such as a blood clot, from using these products, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation. o llame al 1-800-537-1584

Last updated on Feb-7-12

YASMIN BIRTH CONTROL ARTICLES AND INTERVIEWS

Yasmin Complaints Have No Borders

Paris, France: Elina took Yazmine, which is the French equivalent of Yasmin, for more than 10 years before she realized that her health issues are likely related to the oral contraceptive. "I've had gallbladder problems and I have varicose veins and my doctor told me that I need to have them taken out before blood clots form," Elina says. "I can't help but worry that I might develop deep vein thrombosis [DVT] or even worse because of Yazmine. [READ MORE]

Cardiologist and Mass Tort Attorney Discusses Recent Yasmin/Yaz FDA Advisory Panel Decision

Southlake, TX: An FDA advisory panel convened last December 2011 to look into the safety and efficacy of all oral contraceptives containing drospirenone, including Yasmin and Yaz. Dr. Shezad Malik, a cardiologist and attorney, discusses the outcome [READ MORE]

"Good News for Yasmin and Yaz Lawsuits," Says Attorney

Dallas, TX: Cardiologist and attorney Dr. Shezad Malik says the recent Yasmin and Yaz litigation, including other oral contraceptives with drospirenone, is good news for thousands of women who have suffered side effects, which range from gallbladder problems to DVTS to stroke. And even death [READ MORE]