Raloxifene HCl (Evista) Linked to Increased Risk for Stroke-Related Mortality

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On July 17, the FDA approved safety labeling revisions for raloxifene HCl tablets (Evista; Eli Lilly and Co) to warn of the increased risk for death from stroke.

Previously, the agency warned of the increased risk for venous thromboembolism (deep vein thrombosis and pulmonary embolism) in women receiving raloxifene. Use of the drug has now been linked to an increased risk for stroke-related mortality.

In a randomized, double-blind, multinational clinical trial of 10,101 postmenopausal women with documented coronary heart disease or at risk for coronary events, use of raloxifene 60 mg/day for a mean of 5.6 years yielded an increased rate of death from stroke vs placebo (59 [1.2%] vs 39 deaths [0.8%]; 22 vs 15 per 10,000 women-years; hazard ratio [HR], 1.49; 95% confidence interval [CI], 1.00 - 2.24; P = .0499).

However, the incidence of stroke was not statistically different between groups (249 [4.9%] vs 224 [4.4%]; 9.5 vs 8.6 per 1000 women-years; HR, 1.10; 95% CI, 0.92 - 1.32; P = .30), and raloxifene had no significant effect on all-cause mortality.

Accordingly, the risk-benefit ratio should be considered in women at risk for stroke, such as a history of previous stroke or transient ischemic attack, atrial fibrillation, hypertension, or cigarette smoking. Because no cardiovascular benefit was observed in the study, raloxifene should not be used for the primary or secondary prevention of cardiovascular disease.

Raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women.

http://www.fda.gov/medwatch/safety/2007/Jul_PI/Evista_PI.pdf