Yaz: Food and Drug Administration to Discuss Dangerous Contraceptive Pills
Ban demanded / New surveys find increased thrombosis risks / 10,400 lawsuits against BAYER / More than 200 deaths
30 November 2011
Yaz: Food and Drug Administration to Discuss Dangerous Contraceptive Pills
Ban demanded / New surveys find increased thrombosis risks / 10,400 lawsuits against BAYER / More than 200 deaths
The US Food and Drug Administration (FDA) has scheduled an experts' meeting for December 8th. The panel will discuss the future of contraceptive pills containing the active ingredient drospirenone. Recent FDA surveys show that drugs containing drospirenone, such as Yasmin and Yaz, carry a significantly higher risk of causing blood clots than other oral contraceptives. The Coalition Against BAYER Dangers, an international network based in Germany, therefore demands a ban on the sale of those drugs.
Over the past 10 years, the FDA has registered approximately 10,000 individual reports about contraceptive pills. According to these reports, 190 women have died after taking Yaz in the United States alone. A survey the FDA released in late October shows that the thrombosis risk of Yaz users is 75% higher than that of women who use older drugs; the records of more than 800,000 American patients were evaluated for this survey on behalf of the FDA. Two surveys recently published in the British Medical Journal even came to the conclusion that the thrombosis risk caused by drospirenone was 2.3 or 3.3 times higher than the risk caused by drugs containing the hormone Levenorgestrel.
In 2010 BAYER reached a turnover of €1.1 billion (US$ 1.47 billion) from the sale of this group of products, thus making Yaz/Yasmin the best-selling contraceptive pill in the world. Yaz is heavily advertised, especially towards girls and young women, by promising weight reduction and acne relief. However, BAYER does not draw any attention to the more pronounced risk profile associated with products containing the hormone drospirenone. This leads to accidents and fatalities that could have been avoided. In the United States BAYER has already had to pay fines of $20 million for making false claims in advertisements for Yaz. About 10,400 lawsuits are currently pending against BAYER in the US.
The Coalition Against BAYER Dangers, which has been pointing out the dangers of Yaz for years, demands a ban on all contraceptive pills with a profile of increased side effects. 'The purpose of contraceptives is to prevent pregnancy and older drugs do that just as reliably as new ones. Most of the injuries caused by Yasmin and Yaz could be avoided. A change on the leaflet is not sufficient anymore,' says Philipp Mimkes, board member of the Coalition.
There have been at least 12 deaths in connection with the drugs in question in Germany. Women who have suffered from these drugs founded the Self-Help Group of Drospirenone Victims (Selbsthilfegruppe Drospirenon Geschädigter) this spring. Kathrin Weigele, co-founder of the group, says: 'We demand honest information about the risks in pills containing drospirenone and the disclosure of all known side effects. We expect BAYER to finally have a critical look at the numerous surveys from independent scientists that point to a higher danger of thrombosis. This could prevent stories like mine happening again.' Kathrin Weigele suffered a severe lung embolism after taking the pill Yasmin.
Information about the FDA meeting:
· New Birth Control Drugs Tied To Higher Blood Clot Risk: Study
· AP: FDA says Yaz appears to increase blood clot risk
· Agenda for the FDA meeting on Dec 8
Campaign site: www.cbgnetwork.org/3798.html
Self-Help Group of Drospirenone Victims (Selbsthilfegruppe Drospirenon Geschädigter, SDG): www.risiko-pille.de
Coalition against BAYER Dangers
www.CBGnetwork.org (in English)
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Dr. Sigrid Müller, pharmacologist
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Eva Bulling-Schroeter, member of the German parliament
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