PJ Online | News: FDA updates warnings for HRT and over-the-counter spermicides

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The Pharmaceutical Journal
Vol 270 No 7234 p143
1 February 2003

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FDA updates warnings for HRT and over-the-counter spermicides

The United States Food and Drug Administration has added warnings to be given with product information for some hormone replacement therapy (HRT) products.

The FDA has asked all manufacturers of oestrogen and oestrogen/progestogen products used in postmenopausal women to warn that these agents should not be used for the prevention of cardiovascular disease, as highlighted in the Women's Health Initiative Study published last year (PJ, 13 July 2002, p43). They must also highlight findings from the study of increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli and deep vein thrombosis during five years of treatment with HRT compared with placebo.

A spokeswoman for the Department of Health told The Journal that advice on HRT from the Medicines Control Agency would be updated this summer. She added that, since these products were not currently licensed for the prevention of coronary heart disease, no further recommendations would be given on this issue. She repeated guidance given when the study was first published, that the results confirmed previously known findings, that the product investigated in the US was used continuously (rather than cyclically as in United Kingdom treatment) and that the results did not necessitate any immediate changes to therapy.

In addition, the FDA is updating guidance to manufacturers regarding the development of new products for use in postmenopausal women. It intends to work with researchers to find out whether lower doses of hormones produce lower risks, whether other types of hormones or routes of delivery affect risks, and how women can best stop taking oestrogens and progestogens.

Contraceptives containing Nonoxinol-9 The FDA has also proposed a new warning for OTC vaginal contraceptives containing the spermicide nonoxinol-9. It states that these spermicides do not protect against infection from HIV or other sexually transmitted diseases (STDs).

It also advises consumers that these products can increase vaginal irritation, which may increase the possibility of transmitting the AIDS virus and other STDs from infected partners. These proposed statements were based on recent research including a four-year World Health Organization study.