Yaz Deep Vein Thrombosis
Yaz, Yasmin and Ocella are oral contraceptives that have been marketed by drug manufacturer Bayer to young women looking for a convenient and effective means of birth control. Yaz is additionally indicated for women in need of birth control who also want to treat premenstrual syndrome and mild acne. Reports of serious side effects with these drugs, including blood clots, deep vein thrombosis (DVT), and stroke, have led some women to seek alternative methods of contraception.
Yaz, Yasmin, and Ocella contain a new synthetic generation of progesterone known as drospirenone, which has been linked to a higher risk of blood clot and stroke in female users. Deep vein thrombosis involves blood clot formation, and can proceed to a more serious condition, and even death, if it is left unchecked. The Food and Drug Administration (FDA) released an official safety communication in 2011 warning the public that, “drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.”
Deep vein thrombosis (DVT): An overview
Yaz deep vein thrombosis or DVT is a condition where blood clots form in the deep veins of the body, often in the legs. When blood thickens in a vessel, it can clump together and eventually form a clot. Patients that develop DVT often don’t know they have the condition until it becomes advanced enough to produce symptoms.
The blood clot may grow, producing restricted blood flow to the lower extremity, a condition known as limb ischaemia. When less blood is flowing into the leg, less oxygen is getting to the vessels and tissues of the limb. Serious infections and leg ulcers can occur, which may be difficult to treat and carry a high recurrence rate.
The clot might also break free from its original location and travel through the bloodstream to the lungs, where it can result in a pulmonary embolism. It might also travel to the heart or brain, where it can lead to a heart attack or stroke. All of these conditions may be life-threatening, requiring emergency medical treatment.
Signs and symptoms of DVT
Many individuals have no symptoms with Yaz-related deep vein thrombosis, leaving them unaware of their condition unless it progresses to a more serious level.
Patients might experience the following symptoms of DVT:
- Pain or swelling of the affected limb
- Discoloration of the skin in the vein area
- Warmth near the location of the blood clot
- Superficial veins become more visible on the surface of the skin
If the condition progresses to a pulmonary embolism, the individual may experience shortness of breath, pain while breathing, and coughing up blood. These symptoms signify a potentially life-threatening complication of DVT and immediate medical help is needed.
Treatment options for DVT
Once Yaz deep vein thrombosis is diagnosed, treatment is focused on preventing growth of the current blood clot and the formation of additional clots. This is typically done through the administration of blood-thinning medications. However, these drugs are not effective in eliminating a clot that has already formed.
Clots that present a serious danger to the patient may be broken down through thrombolytic drugs administered intravenously. However, this treatment carries a risk of uncontrollable bleeding, so it is only done in severe situations, and under careful observation of medical staff. Treatment for DVT may take a number of months to complete, costing the patient a significant amount of time and money.
DVT risk factors
Some individuals are at higher risk of DVT than others.
Risk factors for deep vein thrombosis include:
- History of venous disorders or blood clots
- Genetic blood disorders that make blood more prone to clotting
- Current or recent treatment for cancer
- Advanced age
- Overweight or obese
- Current smokers
The Yaz product label warns that this drug may not be right for all patients. The label states patients should not take the oral contraceptive if they have a history of one of the following:
- Liver disease
- Blood clots
- Cerebrovascular disease
- Coronary artery disease
- Kidney disease
- Breast cancer
- Hypertension not controlled through medication
While the warning label appears to encompass a number of DVT risk factors, some women who have not fallen into these categories have developed deep vein thrombosis and other serious Yaz side effects. Many of these women were young and in good health at the time of their diagnosis.
FDA and Yaz deep vein thrombosis
Problems between Bayer and the FDA involving Yaz began long before serious side effects like deep vein thrombosis were reported. After the drug was approved for sale to the general market in 2006, Bayer received repeated warnings from FDA representatives for its overblown marketing claims. The company was marketing the oral contraceptive for the treatment of premenstrual disorder and acne, although it had not been approved for these purposes. It was also touted as a birth control choice for young, hip women, while side effect risks were understated.
In 2011, amid numerous reports of Yaz and Yasmin side effects and a number of deaths allegedly linked to the drugs, the FDA began an investigation. The agency updated the warning label for the drug in 2012, stating research that indicated those using the oral contraceptive had a three-fold increase in the risk of blood clots.
Yaz lawsuits involving DVT
The number of Yaz lawsuits filed across the country continues to increase, with nearly 12,000 of those complaints currently coordinated into a single federal court in Illinois. Some of the more recent filings include:
- A complaint recently filed in California Superior Court, involving eight plaintiffs alleging a variety of side effects, including Yasmin & Yaz deep vein thrombosis. The plaintiffs in the complaint state that Bayer failed to properly warn them about the potential risks associated with Yaz, Yasmin and Ocella.
- Brandy Armantrout of Oklahoma, filed a complaint after she had to have her left arm amputated. Armantrout had developed deep vein thrombosis after a number of blood clots formed in the deep veins of her arm. The clots cut off circulation to her lower arm, leaving doctors no choice by to amputate. Armantrout is now seeking legal compensation from Bayer for the cost of a prosthetic, which her insurance will not cover.
- Veronica Malueg filed a lawsuit in Illinois District Court, alleging her Yaz use led to deep vein thrombosis and gall bladder inflammation. Malueg states she continues to suffer physical pain and the need for ongoing medical treatment to this day.
- Courtney Morris of Mississippi filed her lawsuit on February 26, 2013. Morris stated in her complaint that use of a generic form of Yaz led to the development of deep vein thrombosis that eventually resulted in a stroke. Morris is now left with impaired eyesight and partial paralysis of her right side.
Additional Yaz litigation continues to be filed, as awareness of the potential dangers of the oral contraceptive grow. Yaz deep vein thrombosis is one of the most widely reported complications associated with this drug. Patients who are taking Yaz, Yasmin or Ocella and begin to experience the signs of DVT should contact their doctor right away for a proper diagnosis. Early detection of DVT greatly improves a patient’s prognosis and chances for a full recovery.
Resources
- National Institutes of Health, DVT, http://www.nhlbi.nih.gov/health/health-topics/topics/dvt/
- FDA,Drug Safety Communication: Updated information about the risk of blood clots in women taking birth control pills containing drospirenone, http://www.fda.gov/Drugs/DrugSafety/ucm299305.htm