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Third generation oral contraceptives-- the controversy

BMJ 1995; 311 doi: https://doi.org/10.1136/bmj.311.7020.1589 (Published 16 December 1995) Cite this as: BMJ 1995;311:1589

Britain's latest contraceptive pill scare was two months ago (28 October, p 1117). The UK regulatory body, the Committee on Safety of Medicines, asked for presentations from researchers conducting epidemiological studies designed to monitor the risks and benefits of two of the newer synthetic progestogens, desogestrel and gestodene. The new data, unpublished atthe time, suggested that the risk of venous thromboembolism for women taking brands of the pill containing gestodene and desogestrel was twice that for women using longer established brands. Three million women take the contraceptive pill in Britain, and about half of them use these newer brands. Accordingly, the Committee on Safety of Medicines decided that all women using pills containing these hormones available in Britain should be advised of the risk and offered the opportunityto change brands. Germany also issued strict warnings on the use of these third generation contraceptive pills, and other countries have been re-examining the evidence.

International reactions

In Britain the Committee on Safety of Medicines chose not to withdraw the licences of the brands associated with the increased risk, estimated at 30 cases of venous thromboembolism for every 100000 users a year, compared with 15 cases for every 100000 users of other brands. But the committee did write to Britain's 190000 doctors and pharmacists, advising them of its decision. The Department of Health convened a press conference, and the story hit the headlines. Large numbers of women contacted their general practitioners for further advice. Interest was fuelled by a flying visit from the author of one of the unpublished studies on which the committee's decision was based, Professor Spitzer, complaining that the committee had misused his data.

Ms Ruth Grigg, a spokeswoman for the Family Planning Association in …

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