The Department of Health announced last week that third generation oral contraceptives-pills containing gestodene and desogestrel-can now be offered as first line treatment, provided the slightly increased risk of deep vein thromobosis is explained to women.
The measure effectively reverses a recommendation made in 1995 by the Committee on Safety of Medicines (CSM), suggesting that these types of pill should only be used in women who are intolerant to other types. The CSM imposed the restriction after a study suggested a small increase in the risk of deep vein thrombosis. Doctors were advised to switch women to second generation pills. At the time, approximately 1.5 million women-half of all pill users-were taking third generation pills. The warning caused a great deal of anxiety among women and is thought to have led to a major increase in the number of abortions, with the abortion rate increasing by 9%in 1996 and remaining at that level ever since.
Explaining the reason for the change, Dr Jeremy Metters, the deputy chief medical officer, said: “Since 1995, a lot of work has been done and the data have been extensively worked over. The advice from the Medicines Commission now is that if women are fully informed that there is a greater risk with third generation pills and have discussed it with their doctor, then third-generation pills should be provided.” The Medicines Commission-a government advisory body-reviewed the evidence, plus additional data, after an appeal was made by pharmaceutical companies manufacturing third generation pills.
From June this year, third generation pills will contain new package inserts, stating the risks of deep vein thrombosis. They will explain that the risk of deep vein thrombosis in women not taking the pill is five per 100000 women per year. This rises to 15 per 100000 in women taking second generation pills, but in those taking third generation agents the risk is 25 per 100000 women per year. This quantified warning of risk will not be included in packs of second generation pills.
The change in advice has been welcomed by family planning organisations, but has also provoked criticism for the original ruling. A spokesperson for the British Pregnancy Advisory Service-the country's largest abortion agency-said that the CSM's advice in 1995 “was a disaster that should never have happened. It caused a massive hike in the rates of unintended pregnancies and undermined general confidence in the pill. We still see women requesting abortion who wrongly believe the pill is dangerous. We welcome the new advice, but feel it is four years too late.”
In reply, Dr Metters stated: “We would have been wrong to have sat on the information in 1995. Now we have got to the end of the process and advised on the wording for package inserts.”