Contraceptives

The popular low dose birth control pills Yaz and Yasmin which contain the synthetic progestin, drospirenone, will take centre stage at the FDA’s public hearings on Dec. 8th. when the FDA’s reproductive health and drug safety committee will be looking at the safety of this  relatively ‘new’ type of progestin.

We all want to know - do low dose birth control pills containing drospirenone increase the risk of blood clots by 74% when compared to other birth control pills on the market?

I’ll post the results of the hearings  but in the meantime  this link  is worth a visit now as the first civil lawsuit launches in Canada against the manufactures of Yasmin, Bayer Inc. .The comments on the article are worth reading too but persevere to page two.

Other low dose birth control pills containing the same dosage (3 mg) of drospirenone as Yaz/Yasmin are:

• Ocella 
• Safyral
• Syeda
• Zarah
• Beyaz
• Gianvi
• Loryna

I am still awaiting the final FDA statement regarding the increased risk of blood clots with the newer low dose birth control pills. The report should be out in December but here is a little more information to hand:

Earlier analysis seems to be backed up by the latest online statements in the British Medical Journal that although there IS a higher venous thromboembolic (VTE) risk carried by the newer forms of progesterone when combined with oral contraceptives containing *30 to *40 μg ethinyl estradiol (synthetic estrogen). However, that risk still remains small, at about 10 in 10,000.The updated analysis included more than 1.2 million non-pregnant 15- to 49-year-old women in Denmark without a history of thrombotic disease.

Progestin -only pills, like the mini pill (low-dose norethisterone or desogestrel alone) or intrauterine devices which released hormones, did NOT have any impact on VTE risk compared with non-users.

Lower estrogen doses were associated with modestly lower VTE risk for oral contraceptives with norethisterone, levonorgestrel, desogestrel or gestodene but NOT with drospirenone.

With the ‘older’, low dose birth control pills (containing levonorgestrel as the type of synthetic progestin) women were still at threefold elevated risk of VTE compared with those not on any hormonal contraception, whereas those on oral contraceptives containing desogestrel, gestodene, drospirenone (Yaz) or cyproterone boosted their risk six to seven times over that of non-users .

For current users of the newer pills, Philip C. Hannaford, MD, of the University of Aberdeen, Scotland, emphasised that the risks appear real and may lead many clinicians to prescribe a combined oral contraceptive with levonorgestrel whenever possible. “It is crucial, however, not to exaggerate the risk — oral contraceptives are remarkably safe and may confer important long-term benefits in relation to cancer and mortality,” Hannaford cautioned.

I’ll follow this issue closely and post again in Dec. or when the FDA releases their latest statement about the risk level of blood clots for users of low dose birth control pills which contain drospirenone (like Yaz).

Primary source: BMJ
Lidegaard Ø, et al “Risk of venous thromboembolism from use of oral contraceptives containing different progestogens and oestrogen doses: Danish cohort study, 2001-9″ BMJ 2011; 343: d6423.