A German government institute recommended that women limit their use of hormone drugs to treat “pronounced” symptoms of menopause and that they take the lowest dose for the shortest possible period.
All female hormone replacement treatments sold in Germany, the world’s third-biggest pharmaceutical market, will be required to carry the same government-issued warnings about increased risk of breast cancer, ovarian cancer, heart disease, stroke and blood clots starting on Nov. 1, according to the Federal Institute for Drugs and Medical Devices.
“For the first time, the risks will be described very concretely and hopefully written in a clear language every patient can read,” Ulrich Hagemann, a spokesman for the Bonn- based institute, said, noting that advisory labels for hormone drugs have varied by brand.
Germany is giving patients stronger warnings after the U.S. National Institutes of Health last year stopped a study of more than 16,000 women taking Wyeth’s Prempro, an estrogen-progestin hormone combination, when it was linked to a higher risk of breast cancer and heart disease. The German review of hormone labels began in February after a European Union working group agreed on changes for the labels.
About 5 million German women take hormone drugs to treat menopause symptoms, including hot flashes, brittle bones, night sweats and vaginal dryness.
Women who took drugs combining estrogen and progestin had a “substantially” higher risk of developing breast cancer than those taking estrogen alone or no hormone treatment at all, according to a study of a million British woman reported earlier this month in the Lancet medical journal.
“Especially the estrogen-progestin combination should only be prescribed or used after an extensive consultation with the patient over consequential risks that can begin in the first year of treatment,” the German institute said in the release. “Treatment should be as short as possible and at the lowest possible dose.”
Breast cancer is the most common cancer among women worldwide, according to the World Health Organization.
Hormone sales in the 13 largest markets were $4.45 billion in the 12 months ended in April, according to IMS Health Inc. Berlin-based Schering AG and Merck KGaA, based in Darmstadt, Germany, are among companies making hormone drugs for women.