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:10/12/2017)... (PRWEB) , ... October 12, 2017 , ... HMP ... the recipient of a 2017 Folio Magazine Eddie Digital Award for ‘Best B-to-B Healthcare ... City on October 11, 2017. , The annual award competition recognizes editorial and design ...
(Date:10/12/2017)... ... October 12, 2017 , ... On Saturday, October 21, the ... – Miles by Moonlight to raise money for the American Heart Association Heart Walk. ... , Teams will work together to keep their treadmills moving for 5 hours. Treadmills ...
(Date:10/12/2017)... , ... October 12, 2017 , ... ... the nation's first interactive health literacy software tool, and the Cancer Patient Education ... of cancer patient education, today announce a new strategic alliance. , As ...
(Date:10/12/2017)... ... October 12, 2017 , ... Vohra Chief Medical Officer ... physician colleagues, skilled nursing facility medical directors and other clinicians at various events ... Care." , "At many of these conferences we get to educate other physicians, ...
(Date:10/12/2017)... ... October 12, 2017 , ... ... presents its enhanced Pepper Flow promotional review platform at the Promotional Review ... increased insight-driven capabilities help marketers streamline the medical, legal, and regulatory review ...
Breaking Medicine News(10 mins):
(Date:9/19/2017)... Sept. 19, 2017 HistoSonics, Inc., a venture-backed medical device company developing a non-invasive, ... tissues, announced three leadership team developments today:   ... ... ... Veteran medical device executive Josh Stopek , PhD, ...
(Date:9/18/2017)... 18, 2017 EpiVax, Inc. ("EpiVax") ... and immune engineering, today announced a new ... (H7N9) vaccine. ... influenza and presents a challenge for traditional ... to be effective. Using state-of-the-art bioinformatics and molecular ...
(Date:9/12/2017)...  Consumer reviews on the independent review site Consumer Affairs ... company for hearing aids, ranking it higher than Miracle Ear ... ... For Hearing Aids ... online store that provides high performance, state-of-the-art, German-engineered hearing aids directly ...
Breaking Medicine Technology: