The U.S Food and Drug Administration (FDA), the equivalent of the Saudi Food and Drug Authority (SFDA), 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. Ziagen 300 mg is registered in Saudi Arabia and is indicated for HIV infections .

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. The U.S. 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. The U.S. FDA will work with the manufacturers of abacavir and didanosine to fully evaluate the risks and benefits associated with the use of these products as part of an HIV treatment regimen.

As soon as this process is complete, SFDA will communicate the conclusions and recommendations to the public.

ACTIONS THAT HEALTHCARE PROFESSIONALS SHOULD FOLLOW:

· Health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drug their patients are taking until the FDA’s review is complete.

REPORT ADVERSE DRUG REACTIONS TO THE SFDA

The public and health professionals are encouraged to report adverse drug reactions the National Pharmacovigilance Center on the Internet at: