Yaz Blood Clots

Blood clots can be good or bad, depending on the situation. Human blood has the natural ability to clot or coagulate to stop excessive bleeding when an injury occurs. Sometimes, however, blood clots can form when they’re not supposed to causing serious injury and even death. It is these types of blood clots that we want to avoid, which is why medications that may increase the risk of clotting should warn patients and doctors of their potential dangers.

Birth control pills, which are formulated with two types of hormones—estrogen and progestin—help to prevent pregnancy. Under certain circumstances they can increase a woman’s risk of blood clots and related health consequences. Though all hormonal contraceptives carry this possibility, recent studies have found that some create a greater risk than others.

The pills more likely to increase risk of blood clots include those made with a newer progestin called drospirenone. Called a “fourth-generation” progestin, this synthetic hormone is made differently than older types, such as levonorgestrel. This difference has proved to be more dangerous for women at risk for blood clot disorders.

Manufacturer Bayer markets the birth control pills Yaz and Yasmin, which both contain drospirenone. Since 2012, Bayer has been negotiating lawsuit settlements to compensate women who have been seriously injured by Yaz blood clots. Patients who filed lawsuits because of Yaz side effects claim that Bayer should have done more to warn consumers and doctors of the increased risk, so they could have been more informed before taking the drugs.

Yaz blood clots can cause other health problems

Yaz blood clots can form in various areas of the body. When they occur, they can result in severe complications. For example:

• Lung: blood clots that travel to the lungs can lead to a pulmonary embolism
• Brain: blood clots that move to the brain can cause a stroke
• Legs: blood clots that form in the leg veins can travel to the brain or lungs, causing life-threatening situations
• Coronary artery: blood clots that lodge in the arteries that feed the heart muscle can lead to a heart attack

Women who have taken Yaz and Yasmin and developed blood clots have experienced the following complications:

• Pulmonary embolism occurs when a blood clot blocks one or more of the arteries in the lungs. Usually, this happens when a clot travels from a vein in the leg up through the body and into the lung arteries. Symptoms include a sudden shortness of breath, chest pain, wheezing, and cough. A Yaz pulmonary embolism can be life threatening and requires immediate treatment.
• Deep vein thrombosis (DVT) may result when blood clots develop in the deep veins in the legs, or in one of the other deep veins in the body. It can cause leg pain, swelling, and changes in skin color, but some women feel no symptoms at all. This condition becomes dangerous is the clot breaks off and travels up to the lungs or brain.
• A stroke can occur if a blood clot travels to the brain, slowing or completely blocking the flow of blood to brain tissue. Though early action can minimize brain damage, this is a potentially fatal condition as well. Symptoms may include trouble walking or speaking, paralysis or numbness of the face, arm, or leg, vision disturbances, or a sudden headache.
• A heart attack can result when a blood clot forms or travels to the coronary arteries, blocking blood flow to the heart. This can cause damage to the heart muscle itself, and can also result in death. Early detection and treatment is crucial. Symptoms include chest pain or pressure, arm pain, shortness of breath, sweating, nausea and vomiting, clammy skin, and unusual or unexplained fatigue.

Studies raise concerns about Yaz side effects

Though the FDA approved Yasmin and Yaz in 2001 and 2006, it wasn’t long before reports of Yaz blood clots and other side effects started pouring into the agency’s adverse event database. Meanwhile, scientists were researching the hormones used in birth control pills and discovered some disturbing results.

• September 2011: A study published in the British Medical Journal of Danish women over 9 years showed that birth control pills containing drospirenone were linked to a six-fold increase in the risk of venous thromboembolism, a condition in which a blood clot in the lower leg breaks loose and travels to the lungs. Women taking older pills containing levonorgestrel had only a 3-fold risk of the same condition.
• October 2011: The FDA released a safety communication stating that preliminary results of an FDA-funded study suggested a 1.5-fold increase in the risk of Yaz blood clots for women taking drospirenone-containing birth control products. The agency’s results were based on records for more than 800,000 American women who used the pill between 2001 and 2007.
• November 2011: A study of 330,000 Israeli women found that those who used birth control pills containing drospirenone had a risk of blood clots 43–65 percent higher than those using older birth control pills. The study was published in the Canadian Medical Association Journal.
• October 2012: Research led by Kaiser Permanente found that using drospirenone-containing hormonal contraceptives was associated with a 77 percent increase in the risk of hospitalization for venous thromboemoblic events (VTE) and a fifty percent higher risk for arterial thrombotic events (ATE—blood clots in the arteries) compared to use of other birth control pills. The study was published in Contraception.

FDA warns about Yaz and blood clots

Over the years, the FDA has been very vocal in its warnings about Yaz and Yasmin and other drospirenone-containing pills. Some of their actions have included:

• October 2008: The agency issued a warning letter to Bayer concerning their misleading television advertisements that stated Yaz could alleviate premenstrual syndrome symptoms.
• April 2010: The Yaz FDA warning updated Bayer’s product materials to reflect the risk of thromboembolic disorders and vascular problems.
• May 2011: The agency issued a safety communication noting two newly published studies that reported a greater risk of VTE in women using pills containing drospirenone versus other formulations.
• October 2011: The FDA announced the release of their final report in their examination of blood clot risks.  They found that women taking Yaz and Yasmin had a 1.5-fold increased risk for developing blood clots.
• December 2011: An independent FDA panel recommended that the product labels for all drospirenone-containing products be updated to reflect the dangers and risks of blood clots.
• April 2012: The FDA ordered revised labels on all drospirenone-containing labels to advise patients and doctors of a higher risk of Yaz blood clots.

Bayer defends thousands of lawsuits concerning Yaz side effects

In October 2009, the U.S. Judicial Panel on Multidistrict Litigation (JPML) consolidated all federal Yaz lawsuit cases  into one court in the Southern District of Illinois. Since then, Bayer has negotiated thousands of settlements with plaintiffs suffering injuries caused by Yaz blood clots.

Women who experienced blood clot-related complications after taking Yaz and Yasmin can still pursue compensation in court. Contact a products liability lawyer today for more information about your options for recovering damages.