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A NEW PILL SCARE? HOW DID IT COME ABOUT AND HOW SHOULD WE TACKLE IT?
The controversy around the combined hormonal contraceptives (CHCs) of the so-called third (containing gestodene or desogestrel) and fourth generation (containing drospirenone, DRSP) has reached a highly emotional political dimension in which all those who are professionally responsible for women's health are involved: the national health authorities, the pharmaceutical companies, the professional organisations, the prescribers, the media and the public (i.e. the current or potential users of CHCs).
The – initially scientific – controversy has now led to a public health dispute that culminated in the decision of the French authorities to withdraw the combination containing ethinylestradiol (EE) and cyproterone acetate (CPA) from the market. The potential impact of this measure, namely the loss of confidence in all CHCs, could be quite serious.
WHAT TRIGGERED THIS CRISIS?
Several registry-based studies published in the British Medical Journal, particularly the one based on the Danish Registry, indicated that there is an increased risk of venous thromboembolism (VTE) associated with the intake of third- and fourth-generation combined oral contraceptives (COCs) compared to preparations containing the progestogen levonorgestrel (LNG).1–,5 The relative risk (RR) was around 2, and the absolute attributable risk was estimated to be (dependent on the background prevalence rate) between 2 to 8 per 10 000 users per year.6
A very recent systematic review and meta-analysis of the possible link between treatment with CHCs and VTE concluded that, in this regard, (1) CHCs containing LNG or norgestimate were the safest, (2) those containing desogestrel, DRSP or CPA were associated with a significantly higher risk than CHCs containing LNG, and (3) the augmented risk of VTE found for pills containing gestodene compared to COCs with LNG appeared to be smaller than in earlier studies.7
These results contrast with those of published prospective cohort studies, sponsored by Bayer HealthCare, at the request of …
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