; 7bit MedWatch logo MedWatch - The FDA Safety Information and Adverse Event Reporting Program The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA's review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking. This early communication is in keeping with FDA's commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. Read the complete 2008 MedWatch Safety Summary, including a link to the FDA Early Communication About an Ongoing Safety Review regarding this issue at: Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Buy onliner 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 This service is provided to you at no charge by U.S. Food & Drug Administration (FDA) [ ]. FDA [ ] HHS [ ] GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) . 5600 Fishers Lane . Rockville MD 20857 . 800-439-1420 ; 7bit FDA MedWatch- Ziagen (abacavir) and Videx (Didanosine)- Study Date Indicates A Higher Risk of Heart Attack In Patients Infected With HIV-1 Taking Ziagen Or Videx body { font-size: 12px; font-family: arial, verdana, sans-serif; font-weight: normal; font-style: normal; } { color: gray; font-size: 10px; font-family: arial, verdana, sans-serif; font-weight: 100; } The FDA issued an Early Communication about recent findings of The Data Collection on Adverse Events of Anti-HIV Drugs Study. Data analyses from this study indicate a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen (abacavir) or Videx (didanosine) as part of their drug therapy. The study is a large observational study of 33,347 HIV-1 infected patients living in North America, Europe and Australia. Patients in this study are being followed to evaluate the short and long term adverse effects of treatment with anti-HIV drugs. FDA continues to evaluate the overall risks and benefits of abacavir and didanosine. This evaluation may result in the need to revise labeling for the products. Until the FDA’s review is complete, health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking. This early communication is in keeping with FDA’s commitment to inform the public about its ongoing safety reviews of drugs. As soon as this review is complete, FDA will communicate the conclusions and recommendations to the public. Read the complete 2008 MedWatch Safety Summary, including a link to the FDA Early Communication About an Ongoing Safety Review regarding this issue at: Update your subscriptions, modify your e-mail address, or stop subscriptions at any time on your Buy onliner 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 This service is provided to you at no charge by U.S. Food & Drug Administration (FDA). GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420

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