The U.S. Food and Drug Administration (FDA) is reviewing newly received information on the increased risks of heart attacks for HIV-1 patients who are taking Ziagen or Videx as part of their drug therapy.

Early Communication Warning

The FDA has issued an Early Communication warning after it received information from the study The Data Collection on Adverse Events of Anti-HIV Drugs that showed a higher risk of heart attacks in patients infected with HIV-1, the most common type of Human Immunodeficiency Virus, were taking GlaxoSmithKline’s Ziagen (abacavir) or Bristol Myers Squibb’s Videx (didanosine) as part of their drug therapy.

Although the FDA has stated that it is still reviewing the information, it recommends that health care professionals should evaluate the potential risks and benefits of each HIV-1 antiretroviral drugs (medications for the treatment of infection by retroviruses, primarily HIV) that patients are taking. To view the FDA’s warning, go to: http://www.fda.gov/cder/drug/early_comm/abacavir.htm/.

The study

The Data Collection on Adverse Events of Anti-HIV Drugs Study observed 33,347 HIV-1 infected patients in North America, Australia and Europe and found a higher risk of heart attacks amongst those patients who were taking the drugs. As a result, the FDA has said that the products’ labeling may need to be revised.

Additional information

The FDA has provided the following additional information about the drugs:

• Ziagen. Ziagen, manufactured by GlaxoSmithKine, is used to treat HIV-1 infection in combination with other antiretroviral medications. Ziagen is only proven to work when taken in combination with other antiretroviral medications. Ziagen belongs to the class of drugs known as nucleoside reverse transcriptase inhibitors. Other side effects of Ziagen include fever, rash, nausea, vomiting, feeling tired, diarrhea, loss of appetite, trouble sleeping, joint pain, swelling and shortness of breath. (Source: http://www.fda.gov/Cder/consumerinfo/druginfo/Ziagen.HTM)
• Videx. Videx, manufactured by Bristol Myers Squibb, is an anti-HIV treatment in a class of drugs called nucleoside analogs. Side effects include stomach pain, diarrhea, peripheral neuropathy (nerve damage) and pancreatitis (inflammation of the pancreas.) (Source: http://www.fda.gov/cder/foi/label/2001/videxlbl.pdf)