About Yaz & Yasmin

Yaz and Yasmin are oral contraceptives used to prevent pregnancy. They work by stopping ovulation and impeding the ability of a fertilized egg to attach itself to the uterine lining.  Unfortunately, Yaz and Yasmin can cause a wide array of very serious complications, some of which are life-threatening.  Thousands of women in the United States have sued manufacturer Bayer Pharmaceuticals, charging that the company was aware of the dangerous Yaz & Yasmin side effects but continued to market the drug nonetheless.

What is Yaz & Yasmin?

The FDA approved Yasmin in May 2001.  The drug contained a new form of synthetic, so-called “fourth generation” progesterone called drospirenone.  Bayer Pharmaceutical, which manufactured the medication, claimed that the new product made Yasmin more effective than other types of birth control, despite a lack of supporting evidence.

Three years later Bayer submitted Yaz for FDA approval.  Like Yasmin, Yaz also contained drospirenone. But Yaz contained less ethinyl estradiol than Yasmin and had different dosage instructions.  Unlike the customary monthly birth control regimen of 21 active pills followed by seven placebos, Yaz adopted a schedule of 24 active pills followed by four placebos. Bayer asserted that the new treatment routine would help reduce unpleasant pre-menstrual symptoms (PMS).  The FDA approved the contraception in 2006.

Yaz/Yasmin side effects

Both Yaz and Yasmin cause a number of side effects.

Among the most serious and potentially life-threatening are:

• Blood clots and deep vein thrombosis (DVT)
• Pulmonary embolism
• Stroke
• Heart attack
• Hypertension
• Gall bladder disease
• Liver disease
• Hyperkalemia (high levels of potassium in the blood)
• Immune hypersensitivity, including lupus or anaphylactic reaction
• Cervical cancer and dysplasia
• Inflammatory bowel disease

Other, less serious complications include:

• nausea and vomiting
• breast tenderness or swelling
• increased hair growth and freckles or darkening of facial skin
• weight or appetite changes
• vaginal itching or discharge
• diminished sex drive

FDA warns of Yaz blood clots

In December 2011, the FDA convened a panel to review studies of the risk of blood clots in women taking Yasmin, Yaz, and other birth control pills containing drospirenone.  According to the FDA, two studies conducted in 2007 had found no increased risk among women taking Yasmin and Yaz, whereas two 2009 studies concluded that the risk was 1.5 to 2 times higher among women taking drospirenone compared to women taking birth control pills with different active ingredients.

In May 2011, the British Medical Journal published two articles finding that Yaz and Yasmin caused higher risks of blood clots.  One study of Danish women concluded that drospirenone users were over six times more likely to suffer blood clots compared with women not using oral contraceptives.  The second study found that Yaz and Yasmin increased women’s risks of blood clots by 1.6 times compared to women raking other birth control pills.

The FDA then funded its own study showing that women taking Yaz and Yasmin were roughly 1.5 times as likely to suffer blood clots as were women using other types of birth control pills.

As a result of these studies, in 2012 the FDA ordered Bayer to add a “black box warning” to its Yaz and Yasmin labels.  The “black box” is the FDA’s most serious warning about prescription drug complications.  It is designed to highlight especially dangerous side effects and must appear prominently in all informational materials.

The new label warned physicians not to prescribe Yaz or Yasmin to women with any of several contraindications, including:

• Renal impairment
• Adrenal insufficiency
• High risk of arterial or venous thrombotic diseases
• Undiagnosed abnormal uterine bleeding
• Breast cancer or other estrogen- or progestin-sensitive cancer, now or in the past
• Liver tumor (benign or malignant) or liver disease
• Pregnancy

The new label also identified a number of specific conditions that increased women’s risk of suffering a blood clot.

Conditions associated with an increased risk of making Yaz or Yasmin side effects include:

• smoking, if over age 35
• deep vein thrombosis or pulmonary embolism, now or in the past
• cerebrovascular disease
• coronary artery disease
• heart conditions that can cause blood clots, including bacterial diseases and atrial fibrillation (heart murmur)
• inherited or acquired hypercoagulopathies (blood clotting diseases)
• uncontrolled hypertension
• diabetes mellitus with vascular disease
• headaches with focal neurological symptoms
• migraine headaches if over age 35

Yaz lawsuit updates

As the use of Yaz and Yasmin increased, so did the number of serious complications.  To date over 11,000 women have filed Yaz lawsuits seeking compensation for the injuries caused by the Bayer products.  In 2009, all federal lawsuits were centralized for pretrial processing before Judge David Herndon in the U.S. District Court for the Southern District of Illinois; the case is called In re Yasmin and Yaz (Drospirenone) Marketing, Sales Practices, and Products Liability Litigation, MDL 2100 (S.D. Ill.)

As of April 15, 2014, 9,426 lawsuits were pending in the MDL out of a total of 11,580 that had been filed in federal court.  Bayer has settled some 8,250 lawsuits charging blood clot injuries, including deep vein thrombosis or pulmonary embolism.  The Yaz settlements total roughly $1.69 billion.  According to Bayer’s 2013 Annual Report, about 1,950 of the remaining plaintiffs in the MDL have alleged blood clot injuries.  Bayer asserts that it will continue to consider the option of settling individual claims for venous clot injuries in the U.S. on a case-by-case basis.

In March 2013, Bayer agreed to allocate $24 million to settle lawsuits in which plaintiffs allege they suffered a gallbladder ­injury due to Yaz/Yasmin use.  The settlement was contingent on at least 90% of eligible plaintiffs agreeing to its terms.  As of February 10, 2014, roughly 8,800 plaintiffs had agreed to participate in the settlement, which represents more than 95% of the eligible plaintiffs.  Thus the settlement will go forward.

Bayer also faces 1Yaz/Yasmin class action lawsuits in Canada, and one in Israel.  Additional cases are likely to be filed in the future, as women continue to consult qualified Yaz lawyers after suffering serious and life-threatening complications due to their use of Yaz/Yasmin.

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