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The use of a large-scale surveillance system in Planned Parenthood Federation of America clinics to monitor cardiovascular events in users of combination oral contraceptives.
International Journal of Fertility and Women's Medicine. 1999 Jan-Feb; 44(1):19-30.In response to studies reporting an excess of thrombotic events in women who used oral contraceptives (OCs) containing third-generation progestins, the Planned Parenthood Federation of America (PPFA) launched a retrospective review of clients at all PPFA-affiliated centers during 1993-95. During the 3-year study period, 2,265,087 woman-years of OC use were recorded in clinic drug sale records. All OCs prescribed in this period contained 30 or 35 mcg of estrogen and either norgestimate (21.0%), desogestrel (8.9%), norethindrone (46.6%), or levonorgestrel (23.6%) as the progestin. 70 major thrombotic events among clients using OCs (3 vascular complications per 100,000 woman-years of OC use) were reported to PPFA's risk management division during 1993-95; these included 25 cases of deep vein thrombosis, 20 cases of pulmonary embolism, 22 cerebrovascular accidents, and 3 myocardial infarctions. There were 5 deaths (0.22/100,000 woman-years of use), all from pulmonary emboli. The thrombotic event rates were calculated as the relative risk of complication, comparing the risk of each event for one progestin relative to the other three classes of progestins. The overall risk varied from a low of 1.895 events/100,000 woman-years for norgestimate OC users to a high of 3.969 events/100,000 woman-years for desogestrel OC users, but these differences were not statistically significant. In the progestin comparison, desogestrel users showed elevated risks for pulmonary emboli and fatalities, norgestrel use was associated with an increased risk of deep vein thrombosis, and norgestimate an increased risk of deep vein thrombosis and pulmonary embolism. Generally, these four groups of low-dose OCs appear safer than any previously published study has indicated. In part, this may reflect PPFA's careful prescribing guidelines. In addition to following US Food and Drug Administration contraindications, PPFA affiliates do not provide OCs to women over 35 years of age who smoke more than 15 cigarettes a day.