Yaz and Pulmonary Embolism
From 2007 to 2010, Latonia Jones took Yaz birth control pills at the suggestion of her OBGYN. She was later rushed to the hospital for life-saving surgery; Jones had suffered a stroke, pulmonary embolism, and cardiac arrhythmia. The Florida woman was also forced to undergo gallbladder removal, another alleged side effect of her birth control.
This is not just Latonia Jones’s story. It is the story of thousands of other women, who like Jones took the popular brand of birth control pills and emerged much worse for wear. Women like Brandy Armantrout, an Oklahoma mother who watched her arm die before her eyes, as a blood clot cut off her circulation; insurance won’t pay for her prosthesis. Women like Connie Serrano, who suffered deep vein thrombosis (DVT) and pulmonary embolism, and now reports permanent lung damage, swelling, and impaired legs and veins. Their stories have been told again and again by women who have suffered the side effects of drospirenone, the fourth-generation progestin used in Yaz, Yasmin and Ocella birth control pills.
Studies linking Yaz and pulmonary embolism, or Yaz and blood clots, have now warned the medical community and general public of the increased risk. But Bayer maintains that Yaz and Yasmin have no greater risk of side effects than other oral contraceptives – a statement that seems to contradict the $1.5 billion the manufacturer spent in 2012 on Yaz lawsuit settlements.
What is a pulmonary embolism?
The link between Yaz and blood clots has been studied at length by both medical and legal experts who have consistently found that the birth control pills do expose users of the medication to an increased risk of blood clots. One of the most serious risks of blood clots is not the clot itself, but what can happen if a clot dislodges and begins to travel throughout a woman’s body. If the clot reaches the heart, it can cause a heart attack. If it reaches the brain, it can cause a stroke. And if it reaches the lungs, it can result in pulmonary embolism.
Pulmonary embolism occurs when a blood clot blocks oxygen to the lungs.
During a pulmonary embolism, sufferers may experience sudden symptoms, including:
- Anxiety
- Bloody cough
- Chest pains
- Clammy and blue-tinted skin
- Drop in blood pressure
- Fever
- Rapid heartbeat, or heart palpitations
- Shortness of breath
- Sweating
If left untreated, a pulmonary embolism may result in death without proper treatment. Women who experience such symptoms while taking Yaz, Yasmin, or other drosperinone-containing birth control pills should seek emergency medical treatment.
Treatment for Yaz pulmonary embolism include:
- Administration of anticoagulant drugs like Warfarin or Heparin
- Surgical catheterization to remove the clots
- Vein filters, inserted to impede blood clots from traveling to the lungs; this measure is reserved for patients who cannot take anticoagulants, or for whom these drugs do not have the desired effect.
Research and medical studies link Yaz and pulmonary embolism
Though Bayer would have the public believe that the risk of Yaz pulmonary embolism, deep vein thrombosis and other conditions linked to blood clots is no greater than with other oral contraceptives, scientific research begs to differ. Several studies have demonstrated that not only does there exist a positive link between Yaz and pulmonary embolism, but the risk is greater in women taking Yaz and Yasmin than those taking any other competing birth control pill.
In 2009, the British Medical Journal published a study that showed an increased risk of blood clots in women taking Yaz. In 2011, the journal followed up with a second study, this one showing that women taking Yaz had double the risk of venous thromboembolism (VTE) – when blood clots travel to the heart and lungs, causing possible pulmonary embolism – than women taking other forms of oral birth control.
In October 2011, the FDA released its own study, which showed that women taking Yaz had a 1.5-fold increased risk for blood clots and related side effects. On the heels of these results, in June 2012, a study published in the New England Journal of Medicine detailed Danish research findings after a 15-year analysis on 1.6 million women, aged 15-49 and who were not pregnant. During the study, 3,311 women experienced thrombotic strokes and 1,725 participants suffered heart attacks. The risk of heart attack or stroke was higher in women taking drospirenone, the fourth-generation progestin contained in Yasmin and Yaz. The study also found that risks increase as a woman ages.
FDA warns about Yaz and pulmonary embolism
Since the FDA received the first adverse event reports linking Yaz and pulmonary embolism, blood clots and other side effects, the federal agency has taken action to protect the public since approving Yaz in 2006.
- October 2008: The FDA sends Bayer a warning letter, stating that the manufacturer’s, “TV Ads misleadingly overstate the efficacy of the drug.”
- April 2012: The FDA releases updated consumer warnings, which indicate that Yaz users may be up to three times more likely to develop blood clots than women taking other oral contraceptives.
- April 2012: The FDA requires Bayer to add a black box warning, the most serious, to the Yaz warning label, to inform the public of the dangers of Yaz and blood clots.
Basis for Yasmin and Yaz lawsuits
Patient reports and medical research have demonstrated again and again the tie between Yaz and pulmonary embolism, stroke, heart attack, and other blood-clot related injuries. Now, Yaz lawsuits have to prove Bayer’s wrongdoing. One of the most common allegations states that while Bayer knew, or should have known of the risk of Yaz pulmonary embolism and blood clots, the company acted negligently in withholding this information from the public. Many lawsuits also cite Bayer’s misleading advertising, as well as breach of warranty, fraud and other serious allegations.
More than 11,000 Yaz lawsuits are currently underway against Bayer. Many of these women have suffered blood clots resulting in pulmonary embolism. Their sad stories include:
- A 22-year-old medical resident in Florida, who began taking Yaz in 2005 and experienced bilateral pulmonary embolism in 2009. She lives her life under the shadow of continued risk for stroke, heart arrhythmia and sudden death.
- At just 18 years old, Michelle Pfleger collapsed on her college campus. The young woman later died as a result of pulmonary embolism attributed to her use of Yaz.
- Three months after beginning Yaz, Carissa Ubersox developed blood clots that traveled to her lungs, causing bilateral pulmonary embolism. She was in a coma for two weeks, and awoke blind.
Resources
- FDA, http://www.fda.gov/Safety/MedWatch/SafetyInformation/ucm249859.htm
- Mayo Clinic, http://www.mayoclinic.com/health/pulmonary-embolism/DS00429
- New York Times, http://prescriptions.blogs.nytimes.com/2011/10/26/study-yaz-has-higher-risks-of-blood-clots/
- ABC News, http://abcnews.go.com/TheLaw/studies-find-yaz-risky-leading-birth-control-pills/story?id=14741760#.UXkdXrXvuHg
- Consumer Reports, http://news.consumerreports.org/health/2011/04/yaz-yasmin-new-birth-control-pills-may-pose-a-higher-risk-of-blood-clots.html