Bayer Confirms To German Newspaper There Are 129 Yasmin / Yaz Lawsuits In U.S. As Of Mid-October 2009
(Posted by Tom Lamb at DrugInjuryWatch.com)
From an October 21, 2009 article, "Bayer under pressure as birth control pills linked to blood clots", published by the German newspaper Deutsche Welle, we learn that the popular birth control pills Yasmin and Yaz have come under scrutiny in Europe as well as in the United States.
As reported here previously, Swissmedic is analyzing the safety of Yaz and other drospirenone-containing contraceptives following the death of 21-year old woman in Switzerland who died while using Yaz.
The October 21 Deutsche Welle article starts by pointing to two recent studies published in the BMJ medical journal which found birth control pills containing drospirenone and has almost twice as likely to cause blood clots when compared to older oral contraceptives containing the progestin levonorgestrel.
From there, this German newspaper article about Yasmin and Yaz goes on to focus on what is going on in Germany as regards these Bayer birth control pills:
In Germany, 25-year old Felicitas Rohrer collapsed in July with three thromboses in her lung. Since 2001, seven women in Germany have died while taking a contraceptive from the Yasmin family.
In total, 130 cases of adverse drug reaction have been reported to Germany's Federal Institute for Drugs and Medical Devices. However, not all of them are related to thrombosis, Ulrich Hagemann, head of the institute's department of drug safety, told Deutsche Welle....
Bayer said that it is known that the risk for venous thromboembolism, or blood clots in the veins, can be increased when starting the pill. Earlier studies funded by Bayer concluded that the drospirenone-containing pills held no higher risk than older, so-called second-generation pills.
But "arznei telegram," an independent publication for doctors and pharmacists, said the studies were not valid due to "massive method-related deficiencies."
Next, this October 21 Deutche Welle article focused on what the German drug oversight agency has to say about Yasmin and Yaz:
Ulrich Hagemann from the Federal Institute for Drugs and Medical Devices said 20 out of 100,000 women who take an oral contraceptive from the second-generation, which were developed in the 1970s, develop thromoembolic symptoms. For the newer, third-generation pills - and also for contraceptives containing the hormone drospirenone, like Yasmin - women face a risk twice as high, with 35 to 40 women out of 100,000 experiencing thromboembolic effects each year....
"There is a need from my point of view to change the text" in the product information that accompanies the pills, said Hagemann.
Also of interest is what a Bayer spokesperson had to say to this German paper about the Yasmin and Yaz lawsuits filed in the United States:
Bayer, who earns 1.2 billion euros ($1.8 billion) from the worldwide sales of the Yasmin line, confirmed to Deutsche Welle that it currently faces 129 lawsuits in the United States, brought by women who say they've developed health problems after taking Yaz or Yasmin.
"Bayer is still in the process of gathering information on these cases, and the complaints we have received so far pertained to side effects that are warned about in our approved labeling and the labeling for other oral contraceptives," said spokesperson Friederike Lorenzen. "Bayer will defend itself vigorously against these lawsuits."
Going back to Switzerland, it is expected that the results of the safety analysis concerning Yasmin and Yaz side effects reports will become available sometime later this month.
As they say, stay tuned for more about this emerging drug safety issue.
For a complete collection of our articles about these birth control pills as well as selected news reports about YAZ, Yasmin, and Ocella, see our Focus Page on YAZ / Yasmin / Ocella / Gianvi / Zarah.
P.S. According to an October 22, 2009 Swiss news article about the Swissmedic analysis, the agency's (rather ambivalent) conclusion is: "Birth control pills containing the active ingredient drospirenone carry the same health risks as similar contraceptives on the market."
You can translate and read the Swissmedic Announcement, "Venöse Thromboembolien unter Antibabypillen: Swissmedic informiert über Abklärungen und erinnert an die Vorsichtsmassnahmen", to see if you think this Swiss news article accurately characterizes the agency's conclusion. (10/23/09)
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