Yaz Deep Vein Thrombosis

Drospirenone is a type of progestin used in combined oral contraceptives (COC) such as Yasmin, Yaz and Ocella. Owing to their unique formulation, these birth control pills — which are among the top selling brands both in the United States and abroad — have been linked to fatal blood clots and an increased risk for deep vein thrombosis, or DVT.

Deep vein thrombosis is a serious condition where blood clots (or venous thromboembolisms) develop in the thigh or lower leg. Women with DVT are at greater risk for suffering more severe and potentially life-threatening complications including post-thrombotic syndrome and pulmonary embolism.

While all birth control pills can increase the chance of blood clot formation, multiple studies have shown that drospirenone-containing products like Yaz and Yasmin put women at a three-fold greater risk for VTE compared to pills containing other progestins.

Across the nation, thousands of women have claimed their deep vein thrombosis was caused by Yasmin, Yaz or their generic equivalents, and argue that drug maker Bayer failed to provide adequate warnings on potential side effects.

Many who filed suit also suffered related blood clot injuries such as stroke and pulmonary embolism, leaving them with permanent disability, enormous medical bills and a diminished quality of life.

Causes and warning signs of DVT

Blood clots in the deep veins of the legs can be caused by various factors.

Causes of “deep vein” blood clots include:

• Prolonged inactivity
• Blood vessel damage caused by varicose veins or vasculitis
• Surgery that restricts blood flow to the legs
• Smoking
• Obesity
• Genetic conditions that cause blood clots
• Prior history of congestive heart failure or stroke
• Cancer near a vein
• Pregnancy
• Hormone therapy

Though some people show few symptoms of deep vein thrombosis, the most common indicators of the condition are:

• Leg fatigue
• Swelling in the legs, ankles and feet
• Warmth in the skin
• Visible veins
• An aching or tenderness in one or both legs
• Skin color changes – pale or red

Risk factors such as a family history of blood clot disorders and obesity are two primary suspects in patients who are diagnosed with DVT. However, many young, healthy women who took Yasmin and Yaz under the direction of their physician were diagnosed with DVT, raising the question of drospirenone’s inherent dangers.

The safety of drospirenone – a fourth generation progestin – has been analyzed in several clinical reviews, yielding mixed results in some cases. Research published in the British Medical Journal found that blood clot risks are higher with drospirenone versus previous generations of birth control pills.

DVT treatment and prognosis

Deep vein thrombosis is typically diagnosed through a combination of venography, ultrasound and blood tests. Once diagnosed, the goal of treatment is to prevent blood clots from growing or breaking off and traveling to other parts of the body, resulting in a fatal stroke or pulmonary embolism in the lungs. Therapies can also help alleviate leg pain and swelling and help stop blood clots from recurring.

Blood thinning drugs such as rivaroxaban (Xarelto) or warfarin (Coumadin) are usually prescribed to limit the blood’s clotting ability. In most cases, a patient must stay on the anticoagulant for a prolonged period of time, and may also be asked to wear compression stockings. Seldom, doctors may administer a clot-busting drug when large clots are present or patients are at a greater risk for suffering a pulmonary embolism. A catheter is used to inject the drug into the vein, and as such, carries more risk for bleeding complications or stroke compared to therapy with anticoagulants. In other more severe instances, a venous thrombectomy surgery may be required to remove a vein clot that doesn’t respond to other treatments.

Each of these DVT treatment scenarios generally entails multiple doctors’ visits, hospital and medication bills and potential side effects from blood thinning medications.

FDA cautions about Yaz and deep vein thrombosis

On April 10, 2012, the FDA updated labels for all birth control pills containing drospirenone. The revised Yasmin and Yaz labels report that some trials found a three-fold increase in the risk of blood clots for pills made with drospirenone compared to products containing levonorgestrel or other progestins, whereas other epidemiological studies found no additional risk of blood clots with drospirenone.

A separate study published in the December 2011 Canadian Medical Association Journal determined that: “Use of drospirenone-containing oral contraceptives was associated with an increased risk of deep vein thrombosis and pulmonary embolism, but not transient ischemic attack or cerebrovascular attack, relative to second- and third-generation combined oral contraceptives.”

Recent litigation regarding DVT and Yaz

Throughout the States, thousands of women are demanding that Bayer Healthcare Pharmaceuticals be held accountable for Yasmin and Yaz blood clot-related complications – injuries they argue were avoidable had the drug maker issued adequate warnings.

Some of the recent Yaz lawsuits filed against Bayer include:

• Florida resident Fawn Ligon filed a product liability claim against Bayer, alleging her use of Yaz led to life-threatening complications including deep vein thrombosis. The plaintiff’s complaint was brought on March 11, 2014 and demands general and compensatory damages.
• Forty six year-old Shelly Pitt filed her Yaz lawsuit in Los Angeles Superior Court, where she is suing Bayer on counts of failure to warn, manufacturing defect, negligence, breach of implied warranty, engaging in negligent misrepresentation, deceit by concealment and fraudulent concealment. Pitt asserts that she was diagnosed with DVT as a direct result of using Yaz.
• A joint complaint filed in Los Angeles Superior Court on January 29, 2014 alleges that Yaz caused the plaintiffs to suffer deep vein thrombosis and pulmonary embolism and that Bayer failed to warn the claimants about these risks.

Women who are currently on or have taken Yasmin, Yaz or their generic versions and have been diagnosed with DVT are urged to speak with a product liability attorney to determine their rights to compensation. Bayer has already negotiated settlements with thousands of plaintiffs who suffered blood clot injuries such as deep vein thrombosis, and it is not too late to pursue legal recourse.

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