Women need better warnings of the dangers of the ‘designer contraceptive pill’

In May a jury in the US awarded almost US$14 million to a Chicago woman who suffered a debilitating stroke 13 days after starting to take the popular contraceptive pill Yasmin, writes Stephanie Prior.

She is now wheelchair-bound, paralysed on her left side, unable to fully communicate and requires round-the-clock care. She sued her prescribing doctor for failing to warn her of the potential side effects of the drug, particularly the fact that because she was 35 and had hypertension she was at increased risk of suffering side-effects. These included the risk of developing the blood clot which it’s believed led to the stroke.

There are now an increasing number of cases in the US of women developing blood clots once they were taking Yasmin. Within months of taking the drug they developed severe cramp like pain in the lower part of their leg and were subsequently diagnosed with deep vein thrombosis (DVT), which required treatment.

Most women know that there is an increased risk of DVT if they’re on the pill. This has been the case with each successive generation of oral contraceptives since the sixties. Doctors’ warnings have traditionally been coupled with the statistic that the risk of a blood clot from pregnancy is higher. And how many of us know a woman who’s died of a stroke during pregnancy? That’s right: the so-called risks are microscopic, or so we’ve always thought.

It’s worth noting that all hormonal birth control carries a risk of blood clots. In the 1960s, the oestrogen used in the earliest ‘first generation’ pills raised the risk of clots more than nine fold. A decade later, a second generation of pills containing a much gentler dose of the hormone, coupled with the synthetic hormone progestin, had been developed. Though these second-generation pills were effective and carried a lesser risk of clots, pharmaceutical companies sought to alleviate some of the side effect that women experienced on the pill. The third generation pills contained the progestin desogestrel, and Yasmin/Yaz, a so-called fourth generation pill, contain yet another progestin which is said to alleviate symptoms of PMS.

But some research indicates that pills containing third and fourth generation progestins are nearly twice as likely to cause blood clots as second generation pills (which are still on the market and being prescribed). This does seem to be ludicrous: Who would take a pill that’s more likely to cause a stroke when a lower risk pill is available, and both are available free on the NHS?

Answer: A woman who wants to lose weight. Yasmin/Yaz is known as the ‘designer’ contraceptive pill because some clinical trials have shown that is causes woman to lose rather than put on weight, that facial acne cleared up when they were taking it, and that they didn’t suffer from the low moods associated with some other contraceptive pills. Given that many women are put off taking the pill altogether by the prospect of the classic symptoms of weight gain, spots and depression, Yasmin has seemed to many to be a godsend. This includes GPs and doctors at family planning clinics, who had been finding that women came off older contraceptive pills after only months because they were putting on weight.

However, women stayed on Yasmin for years, reducing the number of unplanned pregnancies and their associated costs. The benefits of these fourth generation pills are so widely accepted that they have deep market penetration and are freely available on the NHS despite the fact that they cost more than their predecessors.

The million dollar question – literally, given the size of recent lawsuits in the US – is whether British doctors are adequately warning women that Yasmin and other fourth generation pills carry an increased risk of blood clots, compared to other oral contraceptives. Are they saying this strongly enough, or are they mentioning weight loss in the same breath, with the result that women are just hearing ‘weight loss’?

We know that all pharmaceutical companies heavily market their drugs to GPs, and that GPs are now more busy and overstretched than they have ever been. Are these dual pressures conspiring against women being encouraged to read the label and the health warning on it? The maker of Yasmin has said it will be increasing the size of health warnings on Yasmin packets. The Medicines and Healthcare products Regulatory Agency (MHRA) has written to 60,000 GPs saying that they must go through a patient checklist when prescribing pills. Will these measures be enough to protect women’s health?

These are some of the questions that lawyers are thinking about: How big does the print of a health warning have to be to excuse a drug manufacturer of any negligence? To avoid accusations of negligence, do prescribing doctors need to warn women of the health risk of a contraceptive pill just once, when prescribing it, or do they need to repeat the warning every time they issue a repeat prescription?

We won’t know the answers unless we see US-style litigation over Yasmin/Yaz in the UK. Hopefully we won’t; hopefully the message will get through in time to women that if they’re older or have any history of DVT they shouldn’t take this pill. It could be argued that any woman who is worried about her long term health rather than her weight and acne should be cautious before taking any pill which carries a higher risk of DVT than others on the market. You can lose half a stone and clear up your skin in a few weeks or months, but you can’t recover in the same way from a stroke. Hopefully British GPs will start urgently reviewing their procedures for making sure women are clearly and appropriately warned of the risks.