FDA insists oestrogen products for menopause carry a warning

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.

The FDA said that because the study concluded that the oral oestrogen increased these risks, it must be assumed that all other products containing oestrogen, including oestrogen patches, creams, and pills, could have similar effects, unless proved otherwise. Until now it was only Prempro's label that mentioned the risks, which are stated in boldface type. FDA commissioner Dr Mark McClellan said: “There is no reason to believe that any other drug is safer than Prempro.”