Navigation Links
FDA Approves Lysteda to Treat Heavy Menstrual Bleeding
Date:11/13/2009

SILVER SPRING, Md., Nov. 13 /PRNewswire/ -- The U.S. Food and Drug Administration today approved Lysteda tablets (tranexamic acid), the first non-hormonal product cleared to treat heavy menstrual bleeding (menorrhagia). Lysteda works by stabilizing a protein that helps blood to clot.

(Logo: http://www.newscom.com/cgi-bin/prnh/20090824/FDALOGO)

Heavy menstrual bleeding is reported each year by about 3 million U.S. women of reproductive age. Women with uterine fibroids may experience heavy menstrual periods. But in most cases, there is no underlying health condition associated with the condition.

"Menorrhagia can be incapacitating for some women," said Kathleen Uhl, M.D., FDA's associate commissioner of women's health. "Heavy menstrual periods can cause pain, mood swings, and disruptions to work and family life."

Tranexamic acid was first approved by the FDA in 1986 as an injection, under the brand name Cyklokapron, and is used to reduce or prevent bleeding during and following tooth extraction in patients with hemophilia, a hereditary bleeding disorder caused by the lack of a blood clotting factor.

The most common adverse reactions reported during clinical trials by patients using Lysteda included headache, sinus and nasal symptoms, back pain, abdominal pain, muscle and joint pain, muscle cramps, anemia, and fatigue. There was a statistically significant reduction in menstrual blood loss in women who received Lysteda, compared with those taking an inactive pill (placebo).

Use of Lysteda while taking hormonal contraceptives may increase the risk of blood clots, stroke, or heart attack, according to Scott Monroe, M.D., director of the Division of Reproductive and Urologic Products in the FDA's Center for Drug Evaluation and Research. 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.

Lysteda is manufactured by Xanodyne Pharmaceuticals of Newport, Ky.

Media Inquiries: Sandy Walsh, 301-796-4669, sandy.walsh@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration


'/>"/>
SOURCE U.S. Food and Drug Administration
Copyright©2009 PR Newswire.
All rights reserved

Related medicine technology :

1. Rogan-Delft Approves Matrox Xenia Series for Use With Zillion Suite
2. FDA approves GlaxoSmithKlines VOTRIENT(TM) for advanced renal cell cancer
3. FDA Approves Seasonal Influenza Vaccine Fluarix for Pediatric Use
4. FDA Approves New Treatment for Advanced Form of Kidney Cancer
5. FDA Approves Elitek(R) (rasburicase) for Management of Plasma Uric Acid Levels in Adults with Leukemia, Lymphoma, and Solid Tumors Receiving Anti-Cancer Therapy
6. FDA Approves Cervarix, GlaxoSmithKlines Cervical Cancer Vaccine
7. U.S. Food and Drug Administration Approves CRESTOR(R) for Use in Pediatric Patients With Heterozygous Familial Hypercholesterolemia
8. Chinese Food and Drug Administration Approves Gabexate Mesylate as Pharmaceutical Raw Material
9. FDA Approves New Indication For Mirena(R) to Treat Heavy Menstrual Bleeding in IUD Users
10. US FDA Approves Extavia(R) - the First in a New Portfolio of Planned MS Therapies from Novartis to Help Patients with this Devastating Disease
11. Video: FDA Approves INVEGA(R) SUSTENNA(TM) for the Acute and Maintenance Treatment of Schizophrenia
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/18/2017)... After the recent election cycle, it is clear ... for medical and recreational purposes are shifting. The evidence shows ... of cannabis, but the focus is coming from both the ... North American legal cannabis market posted $6.7 billion in revenue ... projects sales will grow at a compound annual growth rate ...
(Date:1/17/2017)... , Jan. 17, 2017 Precision medicine ... for the treatment of disease. The approach allows ... to a therapy. The approach studies the individual ... lifestyle and environment. In January 2015, Precision Medicine ... to all diseases with more than one million ...
(Date:1/17/2017)... , Jan. 17, 2017 EU5 Glucose Monitoring ... new report, "EU5 Glucose Monitoring Market Outlook to 2022", ... market. The report provides value, in millions of US ... market segments - Blood Glucose Meters, Blood Glucose Test ... shares and distribution shares data for each of these ...
Breaking Medicine Technology:
(Date:1/18/2017)... Silver Spring, MD (PRWEB) , ... January 18, 2017 , ... ... and financial consultations to families and business owners in central Maryland and the DC ... community. , Heart disease kills 787,000 people nationally every year, making it the #1 ...
(Date:1/18/2017)... N.J. (PRWEB) , ... January 18, 2017 , ... ... delivery technologies and development solutions for drugs, biologics and consumer health products, today ... will be presenting at the upcoming WCBP Conference, to be held at the ...
(Date:1/18/2017)... Hills, CA (PRWEB) , ... January 18, 2017 ... ... of dental problems ranging from gum disease to enamel erosion, and those dental ... the Massachusetts Department of Public Health, many pregnant women are failing to get ...
(Date:1/17/2017)... ... January 17, 2017 , ... Gym Source, America’s leading retailer of ... at South Dixie Hwy in Miami, FL. , “We are elated to be opening ... innovative in-store concept is designed to give clients a seamless and motivating shopping experience.” ...
(Date:1/17/2017)... Phoenix, AZ (PRWEB) , ... January 17, 2017 ... ... new and improved supplement, Healthful-Flex. , The company, owned and operated by ... the public at a reasonable price with the highest level of customer service. ...
Breaking Medicine News(10 mins):