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Yaz, Yasmin and Ocella
Yaz, Yasmin and Ocella (the generic version of those drugs) may increase the risk of blood clots when compared to other birth control pills, potentially resulting in a stroke, pulmonary embolism, deep vein thrombosis, gallbladder disease or other life-threatening injury.
Yaz, Yasmin and Ocella are referred to as combinational oral contraceptives (OCs) because they contain both estrogen and progestins not found in other OCs. These oral contraceptives contain a type of progestin called drospirenone.Drospirenone is known to carry some health risks not seen with other forms of the hormone.
As of February 1, 2012, Bayer reported that there were 11,300 lawsuits pending in the U.S. as a result of the failure to warn women of the increased health risks. This number up from 6,850 just one year before. Bayer anticipates more lawsuits as this litigation moves ahead.
Bayer's 2011 Annual Report, which was released on February 22, 2012, notes that Bayer has reached agreements, without admission of liability, to settle the claims of approximately 70 plaintiffs in the U.S.
Bayer positioned Yaz as the “go-to drug brand for women under 35.”It was the top-selling birth control pill in the U.S and was marketed by Bayer as “a quality of life treatment to combat acne and severe premenstrual depression.
Bayer has also found itself under scrutiny for deceptive claims made while marketing Yaz.In fact, the FDA sent Bayer a warning letter, citing the company for running two false and misleading television ads about Yaz.According to the letter, the ads overstate the drug’s efficacy, promoted it for conditions like premenstrual syndrome for which the drug is not approved and minimized serious risks associated with the drug.In February, 2009, Bayer agreed to spend $20 million on a corrective advertising campaign to counteract misimpressions created by the original television spots.
In March 2011, Bayer announced the results of a large study that offers insight into the increased risk of venous thromboembolism (VTE), or blood clots, when using the Pill. The study notes that the risk of a blood clot is highest during the first year of using the combination oral contraceptives (COC's such as Yaz), and even higher in the first six months of use, as well as greatest when restarting the same or a different Pill after a four week or greater break.
In October 2011, the FDA released the results of a study of 800,000 women that found woman taking Yaz had a 75% greater chance of experiencing a blood clot than woman taking the older birth control pills. In addition, BMJ released their own study of 1.2 million Danish women studied over eitght years which concluded that women who took birth control pills that contain drospirenone (such as Yaz) were at least at twice the risk of venous thromboembolism compared with users of older birth control pills.
9/26/2009 - Health Concerns Over Popular Contraceptives, The New York Times
10/3/2008 - The FDA asks Bayer to correct misleading television commericals. Read the FDA Warning here.
2/1/2011 - In their 2010 Annual Report, Bayer reports that there were 6,850 lawsuits pending in the US on behalf of people injured, some of them fatal, from the use of Yaz. In addition, Bayer reported that additional lawsuits are anticipated.
3/25/2011 - Bayer announces the results of a large study which warns women about the increased risk of blood clots during the first year of using pills such as Yaz as well as an increase in risk when restarting the pill after a four week or greater break. Find the PR Newswire about the study here.
10/24/2011 - British Medical Journal (BMJ), a leading journal for doctors worldwide, published a study involving 1.2 million Danish women at reproductive age that showed Yaz users having at least a 2x risk of venous thromboembolism as compared to users of older birth control pills. Find the BMJ study here.
10/27/2011 - FDA releases a study of 800,000 women finding those taking Yaz had a 75% greater chance of experiencing blood clots than women taking the older birth control pills. Read the FDA Study here.
12/8/2011 - 11 of the 26 members of the FDA Advisory Committee voted that the benefits of using a DSRP-containing oral contraceptive (such as Yaz/Yasmin) do not outweigh the risks.
