THE SHANE FOUNDATION

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For the majority of women, these products are safe, but for a significant percentage, they are risky – even highly risky. The question is – how do you know if you may be at risk?

Since the 1970’s it has been well known that combined hormone-based contraceptives, (made with the progestin levonorgestrel and ethinyl estradiol) increased the level of risk for blood clots. But newer versions, containing the synthetic progestin, (“diospirenone” and other versions) have been shown to increase this risk exponentially. (These risks include deep vein thrombosis, pulmonary embolism, heart attack and stroke).

In Europe, the European Medicines Agency (EMA) in 2001 recommended second-generation COCs, i.e. levonorgestrel containing COCs, monophasic, as the first choice because of the data indicating a lower risk of VTE in this group of users compared with users of third-generation pills (COC containing desogestrel or gestodene). This statement was confirmed in 2013 [European Medicines Agency, 2013] where it was concluded that also drospirenone containing COC implied a higher VTE risk.

There was a strong effort to have these newer drugs removed from the market but the FDA decided that “improved warnings” were sufficient.

Unfortunately, many women don’t read these warnings/disclaimers and the lists of potentially serious side effects. Fewer still, understand them. This problem is exacerbated by a lack of explanation and warnings from prescribing doctors and the mass-marketing of these drugs as common consumer-products driven by the advertising power of gigantic, international pharmaceutical manufacturers.

The official position of the ACOG, (American College of Obstetricians and Gynecologists) is that, since the risk of blood clots in pregnancy far exceeds the risk posed by these contraceptives, they are “statistically, worth the risk”. (See “Conclusions” – “Risk of Venous Thromboembolism Among Users of Drospirenone-Containing Oral Contraceptive Pills” ACOG “Committee Opinion” 11/2012)