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Panel urges FDA to remove warnings on hormonal menopause therapy

BioPharma Dive

The study was stopped early in 2002 after researchers observed an increased risk of breast cancer and heart disease. Those warnings stem from a major study conducted by the Womens Health Initiative , or WHI, which evaluated the use of estrogen plus progestin in postmenopausal women.

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Understanding the evidence used in drug product withdrawals

European Pharmaceutical Review

Between 1999 and 2001, it supported 17 percent of withdrawals, between 2002 and 2011, it supported 26 percent of withdrawals and by 2012 to 2016, 80 percent of withdrawals were supported by observational studies (cohort, case-control, or other epidemiologic design). Meta-analyses contributed least frequently (31.4