New therapy for patients with heavy menstrual bleeding

An oral dose of modified-release (MR) tranexamic acid may offer an effective first-line therapy for patients with heavy menstrual bleeding, according to a recent study published online July 17 in The Annals of Pharmacotherapy.

Sandra L Hrometz, BSPharm, PhD, CGP, professor of pharmacology in the Department of Pharmaceutical and Biomedical Sciences at Raabe College of Pharmacy, Ohio Northern University, in Ada, Ohio, examined past published studies as well as data from FDA to examine the efficacy and safety profile of the oral MR formulation.

She identified 2 clinical trials from which to evaluate efficacy, 3 clinical trials from which to evaluate change in quality of life, and 4 clinical trials from which to evaluate safety.

Her findings showed that tranexamic acid interferes with the binding of plasminogen to fibrin, which results in enhanced fibrin clot integrity. The oral dose can safely and effectively begin at the start of a heavy menstrual cycle and can be taken for up to 5 days per cycle.

She noted that doses may need to be adjusted for women with renal insufficiency. The most common adverse effects were menstrual discomfort, headache, and back pain; however, they were not severe. The most significant safety concerns were related to the risk of thromboembolism.

“MR tranexamic acid offers a new first-line therapy for patients with cyclic heavy menstrual bleeding. It is reported to be safe and effective,” Dr Hrometz wrote in the abstract, adding, “There are no labeled equivalents to MR tranexamic acid for cyclic heavy menstrual bleeding.”