European evaluation concludes third generation pills are associated with a small increase in risk of venous thromboembolismBMJ 2001; 323 doi: https://doi.org/10.1136/bmj.323.7317.828/c (Published 13 October 2001) Cite this as: BMJ 2001;323:828
Women using “third generation” oral contraceptives have a small increase in risk of venous thromboembolism compared with those taking products containing levonorgestrel, but the overall risk is very low with any oral contraceptives, a report published last week by the European Agency for the Evaluation of Medicinal Products has concluded.
The agency report, produced by the Committee for Proprietary Medicinal Products, was based on an ongoing review of the risk of venous thromboembolism. It began in 1995 after three independent epidemiological studies showed an increased risk of venous thromboembolism associated with the use of third generation combined oral contraceptives, containing desogestrel or gestodene, compared with combined pills containing the progestogen levonorgestrel. The latest report includes all available information up to mid-September 2001.
The findings show that venous thromboembolism is a rare side effect of all combined oral contraceptives. “The level of this risk is low, and overall the balance of benefits and risks remains favourable with all available combined oral contraceptives. Thus, there is no reason for women currently using any brand of combined oral contraceptives to stop taking it on the basis of these findings,” the European agency report stated.
The review noted that women using third generation combined oral contraceptives containing desogestrel or gestodene with 30 mg of ethinylestradiol had a small increased risk of venous thromboembolism compared with women using products containing levonorgestrel with the same amount of ethinylestradiol.
The committee found an excess risk of venous thromboembolism during the first year a woman ever uses any combined oral contraceptive. “This information is now being added to prescribing and user information in the UK,” said a spokesperson for fpa, a sexual health charity. “It indicates that if a woman uses any type of pill for a year without suffering a venous thromboembolism, her risk of ever suffering this problem is extremely low,” she added.
Overall, she considered that the European agency's report—which concluded that the increased risk of venous thromboembolism associated with combined oral contraceptives was less than the risk of venous thromboembolism associated with pregnancy—showed no differences compared with a review previously carried out in the United Kingdom.
Schering Health Care, one of the companies that manufactures a third generation pill, said: “The recent assessment announced by the European Agency for the Evaluation of Medicinal Products … is not based on any new information, and there is still considerable doubt whether there exists a true difference in the incidence of VTE [venous thromboembolism] between different pills.”
The controversy surrounding the possible increased risk of serious side effects with third generation oral contraceptives continues with a class action, which has been mounted on behalf of 122 women in the United Kingdom claiming that taking a third generation pill was associated with their developing a range of side effects. Chris Tagg, associate solicitor with the lead solicitors in the case, Houghton and Co, said: “The women are claiming injuries relating to DVT [deep vein thrombosis]—including DVT which resolved, pulmonary embolism, cerebral venous thrombosis, stroke, and some deaths.”
The case will be heard in the High Court, London, starting in January 2002.
The report, Committee for Proprietary Medicinal Products Public Assessment Report—Combined Oral Contraceptives and Venous Thromboembolism, can be found at www.emea.eu.int/