Pill research results in new guidance from CSM
Family planning today 1995: 1
1995
ISSN/ISBN: 0309-1112 PMID: 12319465 Document Number: 298329
The Committee on Safety of Medicines (CSM), upon review of three new pieces of research which indicated that contraceptive pills containing gestodene and desogestrel carried an increased risk of venous thrombosis when compared to some other pills, issued a statement on October 18. Women who were taking Femodene, Femodene ED, Marvelon, Mercilon, Minulet, Triadene, and Tri-Minulet were advised to see their doctor as soon as possible to discuss whether they should change brands. They were urged to continue taking their pill until then; if they did change to a different pill, they should do so without the usual 7-day break. The new research shows that gestodene and desogestrel pills carry twice the risk of venous thrombosis: 30 women in 100,000 per year versus 15 women in 100,000 per year for pills containing levonorgestrel or norethisterone. The risk is 5 in 100,000 per year for women who take no hormones. In response to the CSM statement, FPA issued an information sheet for the public. This was followed by an advice sheet which was sent to doctors, nurses, and other health officials by the FPA with the Faculty of Family Planning and Reproductive Health Care. It included information on risk factors indicating a change in pill brand and guidance on switching formulations. Hundreds of calls from both the public and GPs followed, which indicated the important role of the FPA in briefing professionals about contraception. Two of the studies reviewed by the Committee were published in December 1995 (WHO and Hershel Jick of Boston University). The third study, by Walter Spitzer, is expected in 1996.