Navigation Links
FDA Announces Safety Risk Associated with HIV Drug
Date:2/1/2010

Rare, but serious, liver disorder reported in some patients

SILVER SPRING, Md., Feb. 1 /PRNewswire-USNewswire/ -- The U.S. Food and Drug Administration today announced that non-cirrhotic portal hypertension, a rare, but serious, liver disorder, has been reported in some HIV patients taking Videx/Videx EC (didanosine).

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

Videx is an antiretroviral medicine first approved by the FDA in 1991. Videx EC is a delayed-release version of Videx approved in 2000. Videx/Videx EC is used in combination with other antiretroviral medicines to treat HIV infection in children and adults.

During an 18-year period, 42 cases of non-cirrhotic portal hypertension were reported to the FDA's Adverse Event Reporting System for patients taking Videx/Videx EC. Four patients died from bleeding or liver failure after developing the condition.

Non-cirrhotic portal hypertension occurs when blood flow in the portal vein -- a major vein in the liver -- slows down and leads to severely enlarged veins in the esophagus. These enlarged veins, called esophageal varices, are thin and can break open, resulting in serious, and potentially fatal, bleeding.

The Videx and Videx EC product labels have been revised to help ensure that health care professionals and patients are aware of the risk and the signs and symptoms of non-cirrhotic portal hypertension.

The FDA evaluation concluded that the clinical benefits of Videx/Videx EC in certain patients with HIV continue to outweigh potential safety risks. Videx/Videx EC does not cure HIV infection, may not prevent development of HIV-related illnesses, and may not prevent the spread of HIV to other people.  

Videx/Videx EC is marketed by Princeton, N.J.-based Bristol-Myers Squibb.

For more information:

FDA Drug Safety Communication: Serious liver disorder associated with the use of Videx/Videx EC (didanosine)

http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm199169.htm  

Media Inquiries: Erica Jefferson, 301-796-4988; erica.jefferson@fda.hhs.gov

Consumer Inquiries: 888-INFO-FDA

SOURCE U.S. Food and Drug Administration

RELATED LINKS
http://www.fda.gov/

'/>"/>

SOURCE U.S. Food and Drug Administration
Copyright©2010 PR Newswire.
All rights reserved

Related medicine news :

1. Recondo Technology Announces Omni278 UnitedHealthcare Admission Notification Service
2. Trek Bicycle Announces Title Sponsorship of 2010 Dirt Series
3. Sinovac Announces Exercise of Over-Allotment Option
4. Rapport International Announces Partnership with SDL
5. DBLG Announces Release 1.0 of the HITECH Act Survival Guide: an Open Source Law Initiative
6. Southwest Airlines Announces Recipients of its 2010 Medical Transportation Grant Program
7. Dr. David Williams Announces Launch of New Online Digestion Clinic
8. Code Hennessy & Simmons LLC Announces Sale of Suture Express, Inc.
9. Care Investment Trust Inc. Announces Stockholder Approval of Plan of Liquidation
10. PDL BioPharma Announces Two $0.50 Dividends in 2010
11. AMD Alliance International Announces $10,000 Video Contest
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/2/2016)... ... December 02, 2016 , ... ... launch of its 60-day free trial program for all of the company’s desktop ... offer a truly hassle free experience. , FlexiSpot’s unique desktop risers use an ...
(Date:12/2/2016)... ... ... The annual time frame to change Medicare health and prescription drug coverage, known ... Medicare beneficiaries who are looking to switch from their current plan to a Medicare ... during this period order for their new policy to go into effect in 2017. ...
(Date:12/2/2016)... ... December 02, 2016 , ... With the number of pain management programs available ... must find the one that works for them. When an inventor from Suisun City, ... worked and decided to share it with others. , He developed a prototype for ...
(Date:12/2/2016)... ... December 02, 2016 , ... Dr. Raffi Hovsepian, a leading ... the 2016 “Guide to America’s Top Plastic Surgeons” for seven consecutive years. The ... education, experience, and professional associations. , One the most frequently honored surgeons ...
(Date:12/2/2016)... ... December 02, 2016 , ... Mediaplanet is proud to announce ... covers the innovative treatments, therapeutic technologies, and revolutionized nutrition that are helping patients ... life 6 years in the last 3 decades,” says Dr. Valentine Fuster, a ...
Breaking Medicine News(10 mins):
(Date:12/2/2016)... MONMOUTH JUNCTION, N.J. , Dec. 2, 2016 /PRNewswire/ ... critical care immunotherapy leader commercializing its European Union approved ... in critically-ill and cardiac surgery patients worldwide, announced that ... present at the 9th Annual LD Micro Main ... 8 th , 2016 at the Luxe Sunset Boulevard ...
(Date:12/2/2016)... LYME, Conn. , Dec. 1, 2016  Today, ... has announced the honor of being selected as winners ... include: Simpson Healthcare Executives Website at the PLATINUM level, ... Conversations Training Module at the GOLD Level, and our ... At Simpson Healthcare Executives, we are excited ...
(Date:12/2/2016)... YORK , December 2, 2016 ... of its past losses following Trump,s victory early in ... potential, and fund managers are now predicting an uptick ... at four equities to see how they have fared ... CLDX ), Amicus Therapeutics Inc. (NASDAQ: ...
Breaking Medicine Technology: