FDA Probes Heart Risk From 2 HIV Drugs
FDA Reviewing Heart Attack Data in HIV Patients Taking Ziagen and Videx
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.