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FDA Approves New Indication for Tranexamic Acid
 

The U.S. Food and Drug Administration (FDA) has approved the first nonhormonal product to treat heavy menstrual bleeding in women (menorrhagia). Lysteda (tranexamic acid), manufactured by Newport, KY-based Xanodyne Pharmaceuticals, is an antifibrinolytic agent that prevents the breakdown of blood clots.

 

A synthetic derivative of the amino acid lysine, tranexamic acid (TA) has been available for more than 20 years. It was first approved by the FDA in 1986 as an injection (under the brand name Cyklokapron) to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia. This newly approved indication in tablet form will help address the relatively high national prevalence of menorrhagia. According to the FDA release, heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age.

 

Menorrhagia can be incapacitating for some women,” said Kathleen Uhl, MD, FDA’s associate commissioner of women’s health. “Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life.”

 

Side effects of Lysteda include headache, sinus and nasal pain, back and abdominal pain, muscle cramps, anemia and fatigue. The FDA also noted potentially severe side effects associated with Lysteda, particularly in women who are simultaneously taking hormonal contraceptives. According to Scott Monroe, MD, director of the Division of Reproductive and Urologic Products in the FDA’s Center for Drug Evaluation and Research, using the two drugs may increase the risk of blood clots, stroke or heart attack. Monroe cautioned that women using hormonal contraception should take Lysteda only if there is a “strong medical need,” and if the benefit of treatment will outweigh the potential increased risk.

 

Source: FDA news release dated November 13, 2009

 

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