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Retrovir Images

Generic Name: zidovudine  |  Brand Name: Retrovir

Brand Names: Retrovir

There is an FDA Alert for this drug. Click here to view it.

Special Alerts:

[Posted 03/01/2011] 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 (Ziagen) 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 [abacavir and lamivudine (Epzicom); abacavir, lamivudine, and zidovudine (Trizivir)] 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. For more information visit the FDA website at: [Web] and [Web].

REMS:

FDA approved a REMS for zidovudine to ensure that the benefits of a drug outweigh the risks. However, FDA later rescinded REMS requirements. See the FDA REMS page ([Web]) or the ASHP REMS Resource Center ([Web]).

300 | GX CW3 | 300 mg300 | GX CW3   300 mg
bottle, 60 each Zidovudine 300mg, Oral tablet, white, biconvex, round-shaped, side 1:300, side 2:GX CW3
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