Bayer to Update Yasmin Label in the European Union

On Friday, March 26, 2010, Bayer agreed to update its label for Yasmin, at least in the European Union, to inform women and their doctors of the link between use of the contraceptive and an increased risk of venous thromboembolism (VTE).

VTE is a term used to describe a blood clot (thrombus) in a vein, which may partially or completely block the flow of blood in that vein. If this occurs in one of the deep veins in the body, commonly in the legs, pelvis or arms, it is called a deep venous thrombosis (DVT). The major danger from a deep venous thrombosis is that the clot or part of it may break off and travel through the blood stream to the heart and lungs. This is called a pulmonary embolism (PE) and can be fatal.

Although VTE has a known association with combined oral contraceptives, epidemiological studies have shown that the incidence of VTE associated with levonorgestrel (“second generation pills”) is substantially less than those with desogestrel/gestodene (“third generation pills”).

As discussed in this blog, two epidemiological studies were recently published that assessed the risk of VTE in current users of different types of oral contraceptives. These studies are:

-The venous thombotic risk of oral contraceptives, effects of oestrogen dose and progestogen type: results of the MEGA case-control study, van Hylckama Vlieg, Helmerhorst, Vandenbroucke, Doggen & Rosendaal, BMJ 2009;339:b2921; and

-Hormonal contraception and risk of venous thromboembolism: national follow-up study, Lidegaard, Lokkegaard, Svendsen, & Agger (all of Copenhagen, Denmark), BMJ 2009;339:b2890.

These two important studies in the British Medical Journal contained some very significant findings. First, the studies found that women taking combination oral contraceptives containing the hormone, drosperinone, such as Yaz and Yasmin, have a six to seven time increase in the risk of thromboembolism (including DVT or PE). This risk is closer to third generation birth control pills, which have a higher level of risk than second generation oral contraceptives containing levonorgestrel. (The studies also questioned whether Yaz / Yasmin actually provide any increased benefit for acne or weight loss, and also noted the lack of evidence that these drugs help to alleviate premenstrual symptoms.) Thus, the studies contradict Bayer’s marketing of Yasmin and Yaz, which it claims are just as safe, if not safer than other pills, and have multiple additional benefits, such as improvement of acne and premenstrual dsysphoric disorder.

The Pharmacovigilance Working Party (PhVWP) of the Committee for Medicinal Products for Human Use (CHMP) was the force behind the addition of these two independent studies to now be included on Yasmin’s label.

Bayer, of course, questions “several methodological issues” in these studies and also wants to include two 2007 studies that it sponsored (EURAS and Ingenix). Not surprisingly, Bayer argues that its own studies only found that the risk for VTE was comparable to second generation oral contraceptives containing levonorgestrel.

Well, at least some limited acknowledgement and warning of the increased risk to women is a step in the right direction. Now, if we could work on that U.S. label...

More about Yaz in Bayer's Annual Report

Digging deeper into Bayer's 2009 annual report, it discloses that about 1,100 lawsuits have been filed against it alleging its top-selling Yaz birth control pill causes personal injuries and death.

The disclosure establishes that Bayer’s Yaz problem is far larger than it previously anticipated. The cases are pending in Philadelphia, federal multidistrict litigation in Illinois’ Southern District, New Jersey and California.

The disclosure does not say how many women have died after taking Yaz. Nor does it disclose the problem related to gall bladder disease alleged to be caused by Yaz. Bayer said:

Bayer has also been served with three putative consumer class actions claiming economic loss, one of them also claiming personal injuries. All cases pending in u.s. federal courts have been consolidated in a multidistrict litigation (mdl) proceeding for common pre-trial management.

In addition, two Canadian class actions have been served upon Bayer. Additional lawsuits are anticipated.

Based on what we are seeing, only a small percentage of the cases have been filed. We continue to get new cases in every day, many from new injuries. Hopefully Bayer will soon recognize and admit to the Dangers of Yaz and either recall the drug or add the appropriate warnings.

Bayer also discloses that it is insured for these claims "to the extent customary in the industry."

The number of gall bladder injuries from this pill is truly staggering. The rates of gall bladder disease are more than 10 times greater than that normally seen in this population. Bayer runs the risk of shareholder suits by failing to disclose the magnitude of the gall bladder problem.

Even more troubling are Bayer's plans to expand the Yaz line with "Yaz Plus" and "Yaz Flex." Bayer is adding a folate to Yaz, and no doubt using this trick to extend its patent coverage. Folate is the natural source of vitamin B9 found in a variety of foods, most often, in leafy green vegetables, dried beans, and peas. When folate is used as an additive in foods, generally in bread, grains or breakfast cereal, or when it is taken as a supplement it is called folic acid. It is a vitamin.

If you or a loved one have suffered injury or death from this product you should immediately seek legal advice from an experienced lawyer. We are handling cases in the MDL, Philly and Jersey. We will file your case in the jurisdiction that is most suited for the facts of your case.

Contact us free of charge at our toll-free number (888) 841-9623.

Bayer continues to Profit from Yaz

Bayer continues to profit from its dangerous combination oral contraceptive, Yaz. In its latest financial report for fiscal year 2009 Bayer reported that the YAZ line generated sales of 1.3 billion euros ($1.8 billion), up 4.6 percent compared to the year before.

Quarterly revenue from the company's YAZ family of oral contraceptives was unchanged at 314 million euros ($426 million).

Bayer's fourth-quarter revenue from its HealthCare division reached 4.2 billion euros ($5.7 billion), up from last year's fourth quarter.

The HealthCare unit revenues rose 3.8 percent to 16 billion euros ($21.7 billion), due to growth "particularly in the emerging markets." Sales of pharmaceutical products were up 4.4 percent to 10.5 billion euros ($14.3 billion).

The Company as a whole generated revenue for 2009 of 31.2 billion euros ($42.4 billion), down 5.3 percent compared to 2008.

The flattening out of the increase in revenues from Yaz is a hopeful sign that consumers (and their physicians) are getting the message about the Dangers of Yaz.

If you or or a loved one have been injured by Yaz, Yasmin or Ocella contact us free of charge at our toll-free number (888) 841-9623.