Ocella is an oral contraceptive (the generic form of Yasmin). Many users have reported side effects such as nausea, bloating, acne, and weight gain when they switched from Yasmin to Ocella. Life-threatening side effects include stroke, pulmonary embolism (PE) and deep vein thrombosis (DVT). Ocella contains drospirenone, which is under scrutiny by the FDA because it may increase a woman’s chance of blood clots by 40%.
Do I Have a Ocella 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.
UPDATE
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 Ocella?
Ocella is the generic form of Yasmin, a popular prescription birth control medication. It was approved by the FDA for distribution in the U.S. in 2008, and in its first year, sales were in excess of $170 million. Like Yasmin, Ocella is an oral regimen that must be taken daily. Users are provided with a monthly package, containing 21 active tablets. Each active tablet contains 3 mg of drospirenone and 0.03 mg of ethinyl estradiol (synthetic form of estrogen, a female sex hormone). In addition, seven inactive tablets contain no medication but help a woman stay in the habit of taking the pill regularly.
Ocella prevents pregnancy by inhibiting ovulation. Ovulation is when the ovaries release an egg into the uterus. Ocella also affects the cervix and the lining of the uterus – so even if the ovaries release an egg and it is fertilized, it would not be able to implant into the uterus and grow. This method is very effective at preventing pregnancy. When Ocella is used correctly, only 1 out of 100 women using Ocella as their contraceptive method will become pregnant.
Ocella belongs to the “fourth generation” of oral birth control tablets. Other types of oral birth control that contain drospirenone are Yaz, Yasmin, Beyaz, Zarah, Gianvi, Loryna, Safyral, and Syeda.
Is Ocella different from Yasmin?
Ocella is the generic form Yasmin. A “generic medicine” contains the same amount of active ingredients as the non-generic version. In this case, Ocella contains the same amount of progestin and estrogen as Yasmin.
- ”Drospirenone” is the synthetic progestin in Ocella and Yasmin. They each contain 3 mg.
- ”Ethinyl estradiol” is the synthetic estrogen in Ocella and Yasmin. They each contain 0.03 mg.
Bayer HealthCare Pharmaceuticals, Inc. created and patented Yasmin. When Bayer’s patent expired, Barr Laboratories, Inc. purchased distribution rights for a generic form of Yasmin. Barr then marketed and distributed the product in the U.S. under the generic name “Ocella”.
Though they contain the same amount of active ingredients, many users of Ocella have complained that they experienced bloating, nausea, weight gain, headaches, breast tenderness, and other symptoms when they switched from Yasmin to Ocella.
What are the most serious side effects of Ocella?
Ocella contains drospirenone, a chemical that may increase the amount of potassium in a woman’s blood. High levels of potassium in the bloodstream cause the blood to thicken and coagulate, particularly in the extremities. When blood clots form in the extremities, this is called Deep Vein Thrombosis (DVT). DVT usually occurs in the large arteries in the legs. Symptoms of DVT include pain, swelling, numbness or tingling in the tissue, blurred vision, and slurred speech. If you experience any of these symptoms while taking Ocella, you should consult an emergency physician immediately, because these symptoms are precursors to the most deadly side effects of using Ocella.
p>Usually, the blood clots associated with DVT resolve without causing serious harm. Occasionally, however, they may break loose and travel through the bloodstream. When a blood clot travels through the bloodstream, this is called an embolism. Embolisms are dangerous because they may become stuck in the arteries that supply oxygenated blood to the internal organs. This is called a stroke.
A Pulmonary embolism (PE) is when an embolism obstructs the artery supplying blood to the lung. If left untreated, 30% of people who have a PE will die, most often within the first few hours of the event.
2003 FDA Yasmin Warning Letter
Many women who are currently taking Ocella were initially prescribed Yasmin, before Ocella was available as a cheaper, generic medication. They may have asked their doctor for Yasmin after viewing misleading advertisements.
The 2003 FDA Yasmin warning found that the advertisements could mislead consumers. The ads misrepresented Yasmin as safer than other birth control methods, which was not true, by failing to inform viewers about the serious risk factors associated with using Yasmin.
The FDA said that “women and their healthcare providers must weigh Yasmin’s additional health risks when considering Yasmin over [other contraceptives] without drospirenone.”
Ocella FDA Study Results
All birth control pills increase a woman’s risk of blood clots. Some types of birth control have a greater risk of blood clots than others. Several new studies have investigated the effects of drospirenone-containing oral contraceptives compared with contraceptives that do not contain drospirenone. The findings are clear: Women who take birth control containing drospirenone (such as Ocella) are at a significantly higher risk of developing blood clots than women who use other forms of oral birth control.
- In 2009, two scientific studies found that that a woman may be twice as likely to develop a blood clot compared to women using other forms of birth control.
- In 2011, the British Medical Journal, published two additional studies that found that a woman taking birth control with drospirenone may be up to three times more likely to develop a blood clot.
- On November 7, 2011, MedPage Today reported the results of a study that followed 329,995 women in Israel, and found that the risk of blood clots may be more than 40% higher for women who take drospirenone-containing birth control medicines, compared with women who take older kinds of birth control.
- The FDA study of contraceptives such as Ocella followed nearly 800,000 women. The 2011 FDA clinical study found a 1.5-fold greater chance of suffering blood clots after using drospirenone-containing birth control. The risk is greatest in the first year of taking Ocella.
Do I have an Ocella Lawsuit?
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