[Date Prev][Date Next][Thread Prev][Thread Next][Date Index][Thread Index]

FDA MedWatch - Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack



Title: FDA MedWatch - Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack
MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Abacavir - Ongoing Safety Review: Possible Increased Risk of Heart Attack

including Ziagen, Trizivir, and Epzicom

AUDIENCE: Infectious Disease

ISSUE: FDA updated the public about an ongoing safety review of abacavir and a possible increased risk of heart attack. There has been conflicting information on the potential increased risk of heart attack with abacavir treatment. An increased risk of heart attack (myocardial infarction or MI) has been seen in several observational studies and one randomized controlled trial (RCT) with abacavir. However, an increased risk of heart attack has not been seen in other RCTs and the safety database maintained by the drug manufacturer.

FDA conducted a meta-analysis of 26 randomized clinical trials that evaluated abacavir. This meta-analysis did not show an increased risk of MI associated with the use of abacavir. FDA will continue to communicate any new safety information to the public as it becomes available.

BACKGROUND: Abacavir is an antiviral medication used in combination with other antiretroviral drugs for the treatment of HIV-1 infection.

RECOMMENDATION: Healthcare professionals should continue to prescribe abacavir according to the professional label. Patients should not stop taking their abacavir without first talking to their healthcare professional.

Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm245190.htm

 

Tell us how we are doing:

http://survey.foreseeresults.com/survey/display?cid=d509U9xg0gZVxkMRcoMsQg==&sid=link&cpp[date]=03_01_2011_1358&cpp[type]=S


You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm

Follow MedWatch on Twitter twitter

Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Subscriber Preferences Page. You will need to use your e-mail address to log in. If you have questions or problems with the subscription service, please contact support@xxxxxxxxxxxxxxx.

This service is provided to you at no charge by U.S. Food & Drug Administration (FDA).

FDA HHS

U.S. Food & Drug Administration (FDA) · 10903 New Hampshire Ave · Silver Spring, MD 20993 · 800-439-1420


[CDC News]     [NIH News]     [USDA News]     [Photo]     [Yosemite in Winter]     [Hot Springs Photos]     [Steve's Art]     [Camping in Yosemite]     [Yosemite Photos]     [PhotoForum]     [SB Lupus]     [STB]

Add to Google Powered by Linux