Healthy Skepticism Library item: 18268

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

Publication type: Journal Article

Gottlieb S
FDA insists that oestrogen products for menopause carry a warning
BMJ 2003 Jan 18; 326:(7381):126
http://www.bmj.com/cgi/content/extract/326/7381/126/a

Abstract:

The Food and Drug Administration has announced that manufacturers of drugs that contain either oestrogen alone or both oestrogen and progestogen together for the treatment of symptoms associated with menopause must include a new warning on the labels. The warning must state that the drugs may increase the risk of heart attacks, strokes, blood clots, and breast cancer.

The announcement comes six months after a women’s health initiative trial, sponsored by the US government, was halted three years earlier than expected (BMJ 2002;325:61).

The large landmark study found that women taking the hormone replacement product Prempro, a combination of oestrogen and progestogen, had a slightly higher risk of heart disease, breast cancer, stroke, and blood clots than women not taking the treatment. Another arm of the women’s health initiative, in which women are taking an oestrogen only product called Premarin, is ongoing.

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