FDA warn that drugs can cause heart attacks
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.