Yasmin is an oral contraceptive containing drospirenone, which the FDA has linked to serious, life-threatening side effects, such as stroke, heart attack, deep vein thrombosis (DVT) and pulmonary embolism (PE). New evidence has prompted the FDA to issue a safety announcement because drospirenone may significantly increase a woman’s risk of thromboembolic disorders.
Do I Have a Yasmin Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one has been injured by blood clots, you should contact our lawyers immediately. You may be entitled to compensation by filing a lawsuit.
August 1, 2012 — Bayer is continuing to settle Yasmin lawsuits at a consistent pace. Of the 12,000 lawsuits currently pending, Bayer has already paid more than $400 million to settle 1,900 Yasmin lawsuits from women who suffered venous blood clot injuries. The average settlement for these venous blood clot cases is $212,000. Analysts expect Bayer may be forced to pay $2.5 billion to settle or litigate the remaining 10,000 lawsuits.
New Yasmin Safety Warnings
April 2012 — The FDA has recently announced that it will be updating the drug safety information for all birth control pills containing drospirenone. In a statement, they said: “The FDA has concluded that drospirenone-containing birth control pills may be associated with a higher risk for blood clots than other progestin-containing pills.” The FDA will be updating the drug safety information to warn about the increased risk of blood clots associated with drospirenone.
What is Yasmin?
Yasmin (commonly known as “the pill”) is manufactured by Bayer HealthCare Pharmaceuticals Inc. The FDA has approved Yasmin to prevent pregnancy, and when it is used correctly, Yasmin is 99% effective at preventing pregnancy.
Yasmin belongs to the “fourth generation” of birth control tablets that contain drospirenone, which is a new, synthetic form of the female sex hormone progestin. Yasmin prevents a woman’s ovaries from releasing an egg (ovulation), and also changes the lining of the uterus and cervix. In the event that the ovaries release an egg, it is unlikely that the egg will be able to implant in the uterus.
Yasmin is a pill intended to be taken every day. A package of Yasmin consists of 21 active tablets. Each tablet contains 3 mg of drospirenone and 0.03 mg of ethinyl estradiol (synthetic estrogen). There are also 7 inactive tablets – these do not contain any medication, but help a woman stay in the habit of taking a pill every day at the same time.
What is the problem with drospirenone?
Drospirenone increases the level of potassium in a woman’s body. High levels of potassium in the bloodstream increase the likelihood that blood clots will form.
Five new studies have shown that women who use birth control containing drospirenone, such as Yasmin, may have an increased risk of developing blood clots and other life-threatening thromboembolic disorders.
FDA Study of Drospirenone
Several studies were conducted after Yasmin and other “fourth generation” contraceptives had already gone to market and were being used by millions of women. One study in Great Britain found that during 2005-2006, roughly a quarter of women in the country were using birth control containing drospirenone. In 2001, 12 million women in the U.S. were using an oral contraceptive with drospirenone.
- In 2009, two studies were published concerning the use of “fourth generation” pills versus other forms of oral contraceptives. The 2009 studies found that women who use birth control with drospirenone may be twice as likely to develop a blood clot
- The British Medical Journal published two additional studies in 2011. A woman who takes drospirenone-containing birth control may be up to three times more likely to develop a blood clot.
- In November 2011, researchers published the results of a study that followed 329,995 women in Israel. They found that the risk of blood clots may be more than 40% higher for women who take drospirenone-containing birth control medicines instead of other oral birth control.
The FDA’s most recent study is far greater than any of the previously published studies. The FDA followed nearly 800,000 women – comparing women who were taking oral contraceptives with and without drospirenone. Their findings affirmed what the previous studies had already found: Women have a roughly 1.5-fold increased chance of developing a blood clot after using drospirenone-containing contraceptives, such as Yasmin.
In October 2011, the FDA announced the preliminary results of the study and issued a safety warning. The FDA found that the women are at the greatest risk of developing an embolism in their first year of taking the drugs.
FDA Warns Yasmin Ads are “Misleading”
In October 2003, the FDA warned that Yasmin advertisements may be misleading to consumers. The FDA was concerned because the commercials falsely represented Yasmin as a safer alternative to other birth control methods, while minimizing the risk factors associated with its use.
The FDA said that “women and their healthcare providers must weigh Yasmin’s additional health risks when considering Yasmin over [other contraceptives] without drospirenone.”
Side Effects of Yasmin
Deep Vein Thrombosis (DVT) is a side effect of Yasmin. DVT is when blood clots form in the body, usually in the major arteries in the legs. Symptoms of DVT may include swelling, pain, numbness in the extremities, slurred speech, or blurred vision. If you experience any of these symptoms while using Yasmin, consult an emergency physician immediately, because you may be at risk of a life-threatening complication.
Blood clots from DVT usually resolve without causing serious injury. In some cases, however, they break loose and travel in the bloodstream. This is called an embolism. If an embolism becomes stuck in the arteries that supply blood to the major organs, such as the lungs, heart, or brain, they could block the supply of oxygenated blood to these organs. The organs will die if they do not receive oxygenated blood. This is called a stroke. If a stroke is not treated quickly, it can be fatal.
- Pulmonary embolism (PE) is when an embolism blocks the supply of oxygenated blood to the lungs. If untreated, 30% of people who have a PE will die, usually within the first few hours of the event.
Other side effects:
- Arterial thromboembolism
- Myocardial infarction
- Cerebral hemorrhage
- Cerebral thrombosis
- Gallbladder disease
- Hepatic adenomas or benign liver tumors
- Idiopathic Intracranial Hypertension (IIH)
- Pseudotumor Cerebri (PTC)
Do I have a Yasmin Lawsuit?
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