Hormone replacement therapies (HRTs) prescribed in the US must now carry warnings that consumers will notice more easily. The “black box” warnings were introduced in January after the Food and Drug Administration reviewed data from the Women's Health Initiative (WHI) Study (CMAJ 2002;167[3]:294).
Health Canada will update its warnings after reviewing the same data, said spokesperson Ryan Baker. “I can't say when that will be,” he added. The department has released a fact sheet outlining the risks and benefits of HRT and continues to advise women to discuss the study's results with a physician.
The US warnings state that HRT should not be used to prevent cardiovascular disease. They also say that because the WHI study reported an increased risk of myocardial infarction, stroke, invasive breast cancer and venous thromboembolism, HRT should be prescribed for the shortest time possible.
The new US warnings appear on labels, in physician prescribing information and on patient leaflets. — CMAJ