Tough to say. It’s in German. And my German skills were at their highest back in high school. During my trip to Munich for the holidays last year, I could competently read road signs and to order a cheeseburger from the local McDonalds. That’s about the extent of my current abilities.
But Bayer is singing the praises of the new report, claiming that it shows YAZ is as harmless as any other birth control pill, particularly regarding deep venous thrombosis. The report was written by officials at Swissmedica (the FDA’s Switzerland counterpart). Swissmedica experts reviewed existing studies. Bayer’s website cites the Swissmedica press release that “contraceptives containing the active substance drospirenone have a comparable safety profile to that of other preparations available on the market.” Then, Bayer states that they’ve examined post-marketing studies on over 42 million women who have taken drospirenone for years, basically implying that the pill is fine.
But what does the press release really say?
The German version is here. Plugged into a little technological wonder called Yahoo! Babel Fish, (the translation is below), the release seems to indicate that drospirenone-containing contraceptives (like YAZ), are a risk factor that doctors should consider when writing prescriptions for birth control. And the press release cites an underlying study that indicates ingestion of drospirenone-containing birth control pills creates a higher risk of deep venous thrombosis (DVT). So, is Bayer stretching the truth in an effort to do damage control, or are they just reporting the facts? I know which side I’m on, at this point.
Here’s the translated press release–a little clunky, but you get the idea:
Venous Thromboembolien under contraceptive pills: Swissmedic informs over clarifications and reminds of the precautionary measures.
22.10.09 – Contraceptive pills, which contain the active substance Drospirenon, are in the risk range of the other preparations available on the market. The risk for women to get a venous Thromboembolie is most strongly increased as with all contraceptive pills in the first year of the income. Those are the most important results of the examination of combined oral Kontrazeptiva, which accomplished Swiss Heilmittelinstitut Swissmedic because of two new international studies since June of this year. In the opinion, the Swissmedic should combine oral Kontrazeptiva therefore only after careful clarification by the physician be used up. During the prescription of contraceptive pills, those with the active substance Drospirenon contained and with the pills of the 3rd generation so-called should be particularly considered factors of risk of venous Thromboembolien, like genetic assessment, predominance, and smoking. If a factor of risk is present, Swissmedic recommends a non-hormonal preventing method.
Since May 2009, the risks of contraceptive pills are discussed intensively into Swiss media. Swissmedic informed http://www.swissmedic.ch/aktuell/00003/01095/index.html?lang=de on their homepage over the most important facts to the risk of venous Thromboembolien (VTE). Together with their humanly Medicines Expert Committee accomplished Heilmittelinstitut an analysis of the most current data and studies to the factors of risk. Particularly two new epidemiological studies from Holland and Denmark were taken from August 2009 under the magnifying glass, which reported over an increased VTE risk in connection with the active substance Drospirenone. The results proved that the risk with the rising age of the woman and higher Östrogengehalt of the pill increases. In the direct comparison in both studies, it was shown that contraceptive pills of the 3rd generation exhibit an approximately two-way increased risk opposite the 2nd generation ones. The risk to get a venous Thromboembolie is to the 3rd generation, with an income of drospirenonhaltigen pills somewhat more deeply than with those. After the conclusion of this current examination, Swissmedic will take up the results to the drug information. This information refers to in detail on the necessary precautionary measures. Women, who want to prevent hormones, should discuss the risks in detail with their physician.