The Pharmaceutical Journal
Vol 269 No 7209 p149
3 August 2002

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Organon Laboratories (www.organon.com)
Schering Health Care (www.schering.co.uk)
John Wyeth & Brother (www.wyeth.co.uk)

Third generation pill "not more risky"

Third generation oral contraceptive pills do not carry a significantly greater risk of causing venous thromboembolism than second generation contraceptives, a High Court judge has ruled.

Dismissing a class action brought by a group of women under the Consumer Protection Act 1987 (PJ, 9 March, p317), Mr Justice McKay said that a paper analysing the lifetime risk of using the third generation pill showed no increased risk. He added that other studies supported this, saying: "I am not satisfied that the effect of the other investigations into the third generation pill is to show, on a balance of probability, that the risk of venous thromboembolism which it carries is more than twice that of the second generation pill. The most likely figure to represent the relative risk is around 1.7." The judge said that "the trial was almost certainly the most exhaustive examination that this question has yet received".

The action had been brought by the women against Organon Laboratories, Schering Health Care and John Wyeth & Brother. The women had claimed that use of their products had caused their thrombotic events and subsequent problems they suffered.

Evidence presented in court stated that the risk of thromboembolism for women not taking oral contraceptives was about five cases per 100,000 women per year. This rose to 15 per 100,000 for second generation pills and 25 per 100,000 for third generation but was less than the 60 per 100,000 risk from being pregnant.