BioSpace.com

Biotech and Pharmaceutical
News & Jobs
Search the Site
 
   
Biotechnology and Pharmaceutical Channel Medical Device and Diagnostics Channel Clinical Research Channel BioSpace Collaborative    Job Seekers:  Register | Login          Employers:  Register | Login  

NEWSLETTERS
Free Newsletters
Archive
My Subscriptions

NEWS
News by Subject
News by Disease
News by Date
PLoS
Search News
Post Your News
JoVE

CAREER NETWORK
Job Seeker Login
Most Recent Jobs
Browse Biotech Jobs
Search Jobs
Post Resume
Career Fairs
Career Resources
For Employers

HOTBEDS
Regional News
US & Canada
  Biotech Bay
  Biotech Beach
  Genetown
  Pharm Country
  BioCapital
  BioMidwest
  Bio NC
  BioForest
  Southern Pharm
  BioCanada East
  US Device
Europe
Asia

DIVERSITY

INVESTOR
Market Summary
News
IPOs

PROFILES
Company Profiles

START UPS
Companies
Events

INTELLIGENCE
Research Store

INDUSTRY EVENTS
Biotech Events
Post an Event
RESOURCES
Real Estate
Business Opportunities

 News | News By Subject | News by Disease News By Date | Search News
eNewsletter Signup
Miles
Km80.5

   

FDA Approves Xanodyne Pharmaceuticals, Inc.'s Lysteda to Treat Heavy Menstrual Bleeding


11/13/2009 2:31:59 PM

Bookmark and Share

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.

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

Read at FDA
Read at AP
Read at BioSpace.com

FDA
AP
BioSpace.com
 
 

ADD TO DEL.ICIO.US    ADD TO DIGG    ADD TO FURL    ADD TO STUMBLEUPON    ADD TO TECHNORATI FAVORITES