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:12/2/2016)... -- Allergan plc (NYSE: AGN ), a leading ... announced Accelerated Share Repurchase (ASR) Program. Logo - ... , ... announced, the Company entered into a variable tenor ASR arrangement ... $10 billion of its ordinary shares. Approximately 40.5 million shares ...
(Date:11/30/2016)... , Nov 30, 2016 ... "US Market Overview for Neuromodulation, Neurovascular, Neurosurgical and Monitoring Devices ... ... The full report suite on the ... fluid external drainage systems, intracranial pressure monitoring devices, detachable coils, ...
(Date:11/30/2016)... Nov. 30, 2016 Varian Medical Systems (NYSE: ... America,s Most JUST Company in the Healthcare Equipment and ... magazine,s inaugural "JUST 100 List." The rankings are ... surveys ever conducted on attitudes towards corporate behavior, involving ... list ranks U.S companies against their peers within 32 ...
Breaking Medicine Technology:
(Date:12/2/2016)... Miami, FL (PRWEB) , ... December 02, 2016 ... ... over 5,100 hot meals to needy individuals and families from eight different sites ... Florida on Thanksgiving Day. Over 1,000 volunteers worked very hard on Thanksgiving morning ...
(Date:12/2/2016)... (PRWEB) , ... December 02, 2016 , ... ‘Tis the ... winners of $1,000 each from the National Family Partnership and the Drug Enforcement Administration ... who decorated their homes and the 10 winning schools who decorated their campuses with ...
(Date:11/30/2016)... ... ... "I hate when the mixture of saliva and toothpaste runs down my toothbrush ... N.J. "I thought that there had to be a way to prevent this mess, ... to prevent saliva and toothpaste from running down the brush handle onto the hand ...
(Date:11/30/2016)... CA (PRWEB) , ... November 30, 2016 , ... ... disorder and mental health treatment has announced the opening of a new residential ... treatment for girls with mental health issues such as severe anxiety, depression, bi-polar ...
(Date:11/30/2016)... ... November 30, 2016 , ... The ... community that the FDA Binding Guidance goes into effect next month. Sponsors whose ... in the FDA Data Standards Catalog. The current FDA Data Standards Catalog specifies ...
Breaking Medicine News(10 mins):