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Ocella Lawsuit


Ocella is a generic form of the birth control Yasmin, similar to Yaz. Though common side effects may include nausea, bloating, and weight gain, Ocella has also been linked to life-threatening blood clots, deep vein thrombosis (DVT), pulmonary embolism (PE) and other thromboembolic disorders.

What is Ocella?

Ocella is a generic form of Yasmin and similar to Yaz, contraceptives approved by the FDA to prevent pregnancy. It prevents the ovaries from releasing eggs, and also changes the cervical mucus and the lining of the uterus. When used correctly, it is more than 99% effective at preventing pregnancy. Ocella was launched in the U.S. in July 2008. In its first year, sales were in excess of $170 million.

Ocella contains a chemical called drospirenone, which is a synthetic form of the female sex hormone progestin. It belongs to the “fourth generation” of birth control that contains drospirenone, including Yaz, Yasmin, Beyaz, Zarah, Gianvi, Loryna, Safyral, and Syeda. The FDA has recently found that new birth control pills containing drospirenone increase a woman’s risk of blood clots.

Ocella provides an oral contraceptive regimen consisting of 21 active tablets, each containing 3 mg of drospirenone and 0.03 mg of ethinyl estradiol. There are also seven inactive tablets, which help a woman stay in the habit of taking a pill at the same time every day.

Is Ocella different from Yasmin?

Ocella is a generic form of the medicine Yasmin. Ocella contains the same amount of progestin and estrogen as Yasmin. The synthetic progestin in Ocella/Yasmin is called “drospirenone”. The synthetic estrogen in Ocella/Yasmin is called “ethinyl estradiol”.

Yasmin was patented by Bayer HealthCare Pharmaceuticals, Inc. When the patent on Yasmin expired, Bayer supplied Barr Laboratories, Inc. with a generic form of Yasmin, which Barr distributed in the U.S. under the generic name Ocella.

Ocella is manufactured by the same company that produces Yasmin, but distributed by another company. Ocella contains the same number of pills, and the same amount of drospirenone and ethinyl estradiol as Yasmin.

However, many users of Ocella have complained of nausea, bloating, weight gain, breast tenderness, and other symptoms when they switched from Yasmin to Ocella.

FDA Yasmin Warning Letter

Many women taking Ocella were initially prescribed Yasmin. They may have been misled by Yasmin advertisements.

In October 2003, the FDA issued a warning regarding Yasmin advertisements. The FDA found that the advertisements were misleading to consumers, because they falsely represented Yasmin as a safer alternative to other birth control methods, while minimizing the risk factors associated with its use.

The risk factors from using Yasmin are serious, and may cause death. The FDA said that “women and their healthcare providers must weigh Yasmin’s additional health risks when considering Yasmin over [other contraceptives] without drospirenone.”

FDA Study & Safety Announcements

All birth control pills increase a woman’s risk of blood clots. However, five new studies have shown that women who use birth control pills that contain drospirenone, such as Ocella, are at a significantly higher risk of developing blood clots than that for women who use other forms of oral birth control.

The FDA reviewed six studies that evaluated the risk of blood clots in women using birth control pills containing drospirenone. Two studies from 2009 reported that a woman may be twice as likely to develop a blood clot compared to women using other forms of birth control. The conclusions of these two studies were corroborated by two additional articles published in 2011 in the British Medical Journal, which reported that a woman taking birth control with drospirenone may be up to three times more likely to develop a blood clot.

The FDA recently conducted its own study, following nearly 800,000 women who were taking forms of birth control with drospirenone, including Ocella. In October 2011, the FDA issued a statement regarding preliminary findings of the study, which found that women have at least a 1.5-fold increased chance of developing a blood clot after using drospirenone-containing birth control, such as Ocella. The risk of developing blood clots is greatest for women in their first year of taking Ocella.

Side Effects of Ocella

Ocella has been linked to the formation of blood clots in the extremities, called Deep Vein Thrombosis (DVT). When these blood clots break loose, they may travel to the lungs, heart, or brain, and block the supply of blood to these organs. If a stroke is not treated quickly, it can be fatal.

  • Deep vein thrombosis (DVT) is a side effect of using Ocella, causing blood clots to form in the large veins in the lower leg and thigh. The blood clot may block blood flow, causing swelling and pain.
  • In the most serious cases, the clot may break away and move through the bloodstream. This is called an embolism. If an embolism travels through the bloodstream, it may become lodged in the heart, lungs, or brain, causing serious injury or death.
  • Pulmonary embolism (PE) is when an embolism travels through the body and becomes lodged in the artery leading to the lung. The resulting lack of oxygen can cause serious injury to the internal organs. If untreated, 30% of people who have a PE will die, usually within the first few hours of the event.

Other side effects:

  • myocardial infarction
  • thromboembolism
  • hepatic neoplasia
  • gallbladder disease
  • hypertension
  • Pseudotumor Cerebri (PTC)
  • Idiopathic Intracranial Hypertension (IIH)

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