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Early Communication about an Ongoing Safety Review of Ziagen (Abacavir) and Videx (Didanosine)
This information reflects FDA's current analysis of data available to FDA concerning this drug. FDA intends to update this sheet when additional information or analyses become available.
FDA has been made aware of recent findings from analyses of data collected from a large observational study of 33,347 HIV-1 infected patients (The Data Collection on Adverse Events of Anti-HIV Drugs [D:A:D] Study). Patients in this study are being followed to evaluate the short- and long-term adverse effects of treatment with selected anti-HIV drugs from the class known as nucleoside reverse transcriptase inhibitors (NRTIs): zidovudine, stavudine, abacavir, didanosine, and lamivudine. These analyses showed that patients who had recently used abacavir or didanosine had a greater chance of developing a heart attack than patients taking other medications. The risk did not appear to increase over time, but remained stable and appeared to be reversible after abacavir or didanosine was stopped.
FDA currently believes analyses conducted with D:A:D Study data are incomplete. However, FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. Until this evaluation is complete, healthcare providers should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking, including abacavir and didanosine.
This information reflects FDA's current analysis of available data concerning these drugs. Posting this information does not mean that FDA has concluded a causal relationship exists between the drug products and the emerging safety issue. Nor does it mean that FDA is advising healthcare professionals to discontinue prescribing these products. FDA is considering, but has not reached a conclusion as to whether this information warrants any regulatory action. FDA intends to update this document when additional information or analyses become available.