FDA approves new drug for heavy menstrual bleeding

AP News
Posted: Nov 13, 2009 3:53 PM

Federal health officials have approved a new drug as the first non-hormonal treatment for heavy menstrual bleeding.

The Food and Drug Administration says Lysteda tablets reduce bleeding by acting on a protein that helps blood clot. The drug is made by Newport, Ky.-based Xanodyne Pharmaceuticals.

The main ingredient in the drug was first approved in 1986 as an injection for patients with hemophilia, an inheritable disease that prevents blood clotting.

The FDA warns that taking Lysteda with hormonal contraceptive drugs can increase the risk of blood clots, stroke and heart attacks. Women should only use the products together if there is a strong medical need, the agency says.