FDA Probes Heart Risk From 2 HIV Drugs

March 28, 2008 — The FDA is reviewing data on heart attack risk in HIV
patients taking the anti-HIV drugs Ziagen and Videx.
The FDA’s review centers on the Data Collection on Adverse Events of Anti
HIV Drugs (D:A:D) study, which includes more than 33,000 HIV patients in North
America, Europe, and Australia.
The D:A:D study is tracking short-term and long-term adverse events of
treatment with anti-HIV drugs.
According to the FDA, analyses of D:A:D data gathered through Feb. 1, 2007,
show that recent use of Ziagen or Videx was associated with an increased risk
of heart attack. “Recent use” refers to current use of the drugs or
using the drugs within the past six months.
“Patients taking either of these drugs had a greater chance of
developing a heart attack than patients taking other medications,” states
the FDA. “The risk did not appear to increase over time, but remained
stable and appeared to be reversible after [Ziagen] or [Videx] were
stopped.”
Heart attack risk appeared to be greater in patients who had other heart
disease risk factors, including smoking, older age, high cholesterol, high
blood pressure, diabetes, and a history of heart disease.
The FDA considers those analyses to be incomplete. Because the FDA’s review
isn’t finished, the FDA isn’t telling anyone to stop using or prescribing
Ziagen and Videx. At this point, the FDA advises patients and doctors to weigh
the risks and benefits of each HIV drug they use, including Ziagen and
Videx.

Drug Companies Respond

Ziagen is made by GlaxoSmithKline.
In a news release, GlaxoSmithKline states that its analyses show no
increased risk of heart attack associated with Ziagen and that no biological
mechanism linking Ziagen treatment to heart attacks has been identified.
GlaxoSmithKline advises patients not to discontinue treatment on their own,
and to minimize modifiable cardiovascular risk factors such as high blood
pressure, high cholesterol, diabetes, and smoking.
“Although the D:A:D study data suggest a relative risk increase in heart
attack risk for patients who are starting or continuing [Ziagen], that risk
remains low in absolute terms, and therefore [Ziagen] remains an important
treatment option for those patients,” states a GlaxoSmithKline news
release.
Videx is made by Bristol-Myers Squibb.
“We have not seen an increase in cardiovascular events in prior studies
of Videx or in our safety database,” Bristol-Myers Squibb spokeswoman Sonia
Choi tells WebMD.