Estradiol Gel (EstroGel) Linked to Risks for Probable Dementia and Ovarian Cancer
On July 25, the FDA approved safety labeling revisions for estradiol 0.06% gel (EstroGel; Ascend Therapeutics, Inc) to warn of the risk for probable dementia and potential risk for ovarian cancer. Estrogen therapy should be limited to the lowest effective dose and for the shortest duration consistent with treatment goals.
Data from the Women's Health Initiative Memory Substudy (n = 2947) have linked daily use of 0.625 mg of conjugated estrogens (CE) monotherapy for an average of 5.2 years to an increased risk of developing probable dementia vs placebo in women aged 65 to 79 years who have undergone a hysterectomy (relative risk [RR], 1.49; 95% confidence interval [CI], 0.83 - 2.66; absolute risk per 10,000 women-years, 37 vs 25).
The FDA notes that a similar increase in risk was observed for women in this age group receiving CE with 2.5 mg of medroxyprogesterone [MPA] daily (n = 4532) for an average period of 4 years (RR, 2.05; 95% CI, 1.21 - 3.48; absolute risk per 10,000 women-years, 45 vs 22).
When data from the 2 groups were pooled, the overall risk for probable dementia was 1.76 (95% CI, 1.19 - 2.60). The relevance of this finding to younger postmenopausal women remains unclear.
The majority of cases occurred in women aged older than 70 years (CE alone, 79%; CE with MPA, 82%); the most common classification in the treatment and placebo groups was Alzheimer's disease.
Findings from the Women's Health Initiative study (n = 10,739) also revealed an increased risk for ovarian cancer in postmenopausal women taking CE with MPA for an average of 5.6 years. However, the risk was not statistically significant vs placebo (RR, 1.58; 95% CI, 0.77 - 3.24; absolute risk per 10,000 women-years, 4.2 vs 2.7).
According to the FDA, the risk for ovarian cancer in women receiving estrogen monotherapy remains unclear: some epidemiologic studies have revealed an increased risk, particularly with duration of therapy of 10 years or more; other studies have not supported these findings.
Estradiol gel is indicated for the treatment of moderate to severe vasomotor symptoms and for moderate to severe symptoms of vulvar and vaginal atrophy associated with menopause.
http://www.fda.gov/medwatch/safety/2...ekturna_PI.pdf
http://www.fda.gov/medwatch/safety/2.../Diovan_PI.pdf
http://www.fda.gov/medwatch/safety/2...stroGel_PI.pdf
Threaded Mode