YAZ or Yasmin are fourth generation combined oral contraceptives (COC’s) containing drospirenone. Drospirenone is a synthetic form of progesterone. Progesterone is a naturally occurring female hormone which is part of the female reproductive system. YAZ or Yasmin have been authorised in the EU since 2000 and the US since 2001.
Why are YAZ and Yasmin in the News?
What are the Regulatory Authorities saying about YAZ and Yasmin?
In 2012 a Federal Drug Administration (FDA) review as a consequence of the above studies and other concerns resulted in two drospirenone class drug labelling changes. The warnings and precautions were updated to highlight the increased risk of venous thrombosis or blood clots.
In June 2011, the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) in a Drug Safety Bulletin stated that ‘Yasmin: risk of VTE may be higher than levonorgestrel-containing pills’. Product Information for Yasmin, as for all COCs, already contains extensive warnings about the risk of VTE and these have been updated to reflect the totality of the evidence.
In January 2013 the European Medicines Agency started a review of the safety of third and fourth generation contraceptives. This followed a request from France where the national regulatory agency has taken measures to reduce their use over concerns about the increased risk of blood clots.
The Irish Medicines Board in their Drug Safety Newsletter June 2011 – noted the following regarding Yasmin (also refers to YAZ and Yasminella):
The risk of VTE has been continuously monitored since approval and in 2010 the product info was updated to reflect data from two studies which indicated that the risk of VTE has been continuously monitored since approval and in 2010, the product information was updated to reflect data from two studies which indicated that the risk of VTE with drospirenone containing COCs was somewhat between the risk associated with levonorgestreal containing COCs and third generation COCs such as those containing gostodene and desogetrel.
YAZ & Yasmin Litigation
YAZ & Yasmin Litigation There are claims that Bayer, the manufacturer of YAZ/Yasmin over-promoted the drug without disclosing the higher risks of blood clots. As far back as 2008 the FDA issued a warning letter ruling that an advertising campaign for YAZ/Yasmin was deceptive and contained false claims.
As of October, 2012 the number of YAZ/Yasmin lawsuits pending in the United States was over 12,400. The plaintiffs allege that by taking Bayer’s drospirenone containing oral contraceptive products such as Yasmin or YAZ, they have suffered personal injuries which in some cases have been fatal. Bayer without any admission of liability reached settlements totalling US$750 million with approximately 3,490 claimants.
CBC News Canada has reported that at least 23 women who died suddenly of blood clots had been taking YAZ and Yasmin. CBC news based this information on documents they have obtained from pharmacists, doctors and Health Canada, the federal department responsible for Canadians’ health. If you believe you have been affected by any of the issues raised in this article please phone us at 01 87 444 22 or email us.
