FDA insists that oestrogen products for menopause carry a warningBMJ 2003; 326 doi: https://doi.org/10.1136/bmj.326.7381.126/a (Published 18 January 2003) Cite this as: BMJ 2003;326:126
- Scott Gottlieb
- 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 …