Observatorio de Bioética, UCV

Yasmin or Yar serious thrombotic effects. Are users well informed?

Informes / Noticias

Yasmin or Yar serious thrombotic effects. Are users well informed?
07 octubre
11:35 2014

Serious ethical problems and responsabilities

Yasmin or Yar. It has recently been reported that the multinational drug company Bayer has had to pay out 1800 million in damages to 8900 women in the United States who suffered medical problems (including death) as a result of having used some of their contraceptive products, namely Yasmin or Yar, which contain drospirenone.

In a financial report to their shareholders in the second trimester of 2014, the company acknowledged that those affected had indeed suffered personal health conditions (some of them fatal) after using this type of contraceptive, particularly thromboembolic events, which were clearly the most prevalent.
In addition to the 8900 lawsuits that have already been settled, on the 9th of July, Bayer stated that they had a further 5000 lawsuits pending.

10 year 0f silence

However, the most surprising thing about this news, which is terrible in itself, is that the risk of thromboembolic effects due to the use of Yasmin or Yar has been known for more than a decade.

Yasmin is an oral contraceptive containing ethinyl oestradiol and drospirenone that was launched on the market by Bayer and approved by the European Union in 2000 (BMJ,2002;324,869).

Paradoxically, its use was promoted because the German pharmaceutical company believed that it might have fewer thromboembolic side effects than other contraceptives hitherto used.
However, as far back as 2003, five cases of thromboembolism were described in women, only a few days after they had started taking Yasmin (BMJ 2003; 326,257).

That same year (2003), we also described the case of a young 21-year-old woman who, 15 days after having begun to take Yasmin for contraceptive purposes, felt discomfort in her right arm, with decreased sensitivity. These symptoms persisted for over 24 hours, and were related with a possible stroke. This may have been the first time that the use of Yasmin was associated with a cerebral ischaemic event (Thrombosis Research 2003; 112,121).

What seems remarkable is that when the first thromboembolic events secondary to the use of Yasmin or Yar were detected in 2003, the drug continued to be prescribed and used, as evidenced by the fact that in the United States alone, around 14,000 women had problems after taking it, a figure which could rise, since only those who filed lawsuits against Bayer were counted. In this case, we can see two major ethical problems here, among others. The first is that women have almost certainly not been informed of the risks of using Yasmin, and the second is the laxity of the health authorities for permitting the continued use of this drug, although it has been known since 2003 that it could have major health risks, mainly thromboembolic events.

Are we to believe that if we used another Bayer product, for example aspirin, in which such serious side effects had been found, that it would not have been quickly taken off the market?

We consider that, ultimately, it is not only the pharmaceutical company – in this case Bayer, which with a distinct lack of business ethics continues to distribute a hugely profitable drug – that is to blame, but also society in general, which has shown itself to be very reluctant to speak out against the use of a contraceptive. This is almost certainly because to do so would be considered as going against the sexual freedom of women, when the only aim is to protect their health.

 

Julio Tudela Cuenca Bioetics Observatorory UCVJusto Aznar Lucea Director. Bioethic Observatory - Catholic University of Valencia

      Julio Tudela y Justo Aznar

Yasmin or Yar serious thrombotic effects. Are users well informed?
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SINOPSIS: We consider that, ultimately, it is not only the pharmaceutical company - in this case Bayer, which with a distinct lack of business ethics continues to distribute a hugely profitable drug - that is to blame, but also society in general, which has shown itself to be very reluctant to speak out against the use of this contraceptive. This is almost certainly because to do so would be considered as going against the sexual freedom of women, when the only aim is to protect their health.

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Cristina Castillo Albarran

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