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FDA insists that oestrogen products for menopause carry a warning

BMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7381.126/a (Published 18 January 2003) Cite this as: BMJ 2003;326:126
  1. Scott Gottlieb
  1. New York

    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.

    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 … We want similar labelling on all these products. At the moment we don't have the information to say that one or the other is different.” Five products on the US market contain combinations of oestrogen and progestogens and 15 contain oestrogen alone, the agency said.

    Dr McClellan said that women should consult their doctors about whether to take oestrogen for menopause symptoms. But, he said, “oestrogen and progestin [progestogen] should be used at the lowest doses for the shortest time.”

    The agency has also revised two of the three indications for use of oestrogen. The drugs were indicated for vaginal dryness and irritation, even if there were no symptoms and the condition was noticed only on medical examination. Now, the drugs' labels will state that the condition must be moderate to severe and that women should consider using topical products, such as vaginal creams.

    Although oestrogen can slow the bone loss that occurs with menopause, the new labels must state that when the hormone is used only for prevention of osteoporosis it should be restricted to women who are at highest risk. Even then, the new labels will say, other drugs that do not contain oestrogen should be considered for osteoporosis.

    Oestrogen is still recommended for alleviation of moderate to severe hot flushes and night sweats. “These symptoms can be very disruptive and are often only controlled by oestrogen,” Dr McClellan said.

    The agency advised that women taking hormone therapy should have yearly breast examinations by a health professional, perform monthly breast self examinations, get regular mammography, and discuss other ways to reduce the risk of heart disease and osteoporosis.

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