ST LOUIS (MD Consult) - On November 13, 2009, the US Food and Drug Administration (FDA) announced the approval of Lysteda (tranexamic acid) for the treatment of menorrhagia. Lysteda works by stabilizing a protein involved in the blood-clotting process.

Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron. It is used to reduce or prevent bleeding during and after tooth extraction in patients with hemophilia.

In studies, patients who received Lysteda experienced a statistically significant reduction in menstrual blood loss, compared with patients who received placebo.

The most common adverse reactions reported during clinical trials by patients receiving Lysteda included headache, muscle cramps, anemia, fatigue, sinus and nasal symptoms, and back, abdominal, muscle, and joint pain.

The FDA warns that the use of Lysteda while taking hormonal contraceptives may increase the risk of blood clots, stroke, or myocardial infarction. The agency advises that women receiving hormonal contraception take Lysteda only if a strong medical need exists and if the perceived benefit outweighs the potential increased risk.

 

圣路易斯(MD Consult) —— 2009年11月13日，美国食品药品管理局(FDA)宣布批准Lysteda (氨甲环酸)用于治疗月经过多。Lysteda是通过稳定一种参与凝血过程的蛋白而发挥作用。

氨甲环酸的注射液于1986年被FDA首次批准，商品名Cyklokapron，用于减少或预防血友病患者拔牙期间或拔牙后出血。

 

临床试验表明，与服用安慰剂的患者相比，服用Lysteda的患者经期失血量显著减少，差异有统计学意义。

 

根据临床试验报告，服用Lysteda的患者最常见的不良事件包括头痛、肌肉痉挛、贫血、疲劳、鼻窦和鼻腔症状、腰背、腹部、肌肉和关节痛。

 

FDA警告服用激素类避孕药期间使用Lysteda可增加血液凝结、卒中或心肌梗死的风险。FDA建议采用激素避孕的女性仅在有强烈医疗需求且治疗受益大于可能增加的风险时才服用Lysteda。