AIDS drug side effects could double the risk of heart attacks
Data collected from a recent study involving various AIDS drugs have suggested that Videx and Ziagen side effects could increase the risk of a heart attack when compared to other HIV medications in the study. The data was published online Tuesday by the medical journal Lancet, and the FDA issued an early communication about the possible Videx and Ziagen heart attack risks late last week.
>>FDA EARLY COMMUNICATION: Review of Videx and Ziagen Heart Attack Risk
Videx (generic didanosine) and Ziagen (generic abacavir) are part of a class of medications known as nucleoside reverse transcriptase inhibitors (NRTIs), which are used for treatment of HIV. The information about a possible increased risk of heart attacks associated with these AIDS drugs comes from a large observational study of 33,347 HIV-1 infected individuals living in North America, Europe and Australia.
The research, known as the D:A:D Study (The Data Collection on Adverse Events of Anti-HIV Drugs Study), evaluated the short and long-term HIV drug side effects, including the risk of heart attacks, among users of a variety of NRTI drugs. Users of Videx and Ziagen were found to have a greater chance of developing a heart attack when compared to those taking other AIDS drugs in this class.
Ziagen, which is manufactured by GlaxoSmithKline Plc, seemed to carry the greatest risk, with a 90% increase in the risk of heart attacks. The medication is also a component of other AIDS drugs, including Trizivir, Epzicom and Kivexa. The combined sales in 2007 of these AIDS drug was over $1 billion.
Videx, which is used by less individuals and is available as a generic under the name didanosine, is manufactured by Bristol-Myers Squibb Co.. Didanosine was associated with a 49% increase in the risk of heart attack.
The risk of Videx and Ziagen heart attack side effects was found to be greater among those with other risk factors for heart disease, such as high cholesterol, high blood pressure, diabetes, smoking and age. The data did not indicate that the risk increased over time, and it appeared to be reversible, with no increased risk seen 6 months after stopping the drugs.
The FDA issued an early communication, which means that they are continuing to investigate the emerging safety issue, but that they have not concluded a causal relationship between the AIDS drug and the increased risk of heart attacks found in the study. The drug regulatory agency has not reached any conclusions about the data, and is evaluating whether any actions are warranted, such as strengthening of the drug labels.
Experts have pointed out that AIDS drugs are used in combination with other drugs, so they could be swapped for other medications if necessary. Some financial analysts have suggested that the concerns about Ziagen side effects could lead to a number of physicians changing their patients to Gilead-based regimens. The FDA has indicated that healthcare providers should evaluate the potential risks and benefits of each drug, but they have not indicated that the medications should be stopped based on the information available at this time. Certainly, no medication should be discontinued without the supervision and knowledge of a doctor.
The product liability lawyers at Saiontz & Kirk, P.A. are closely following the evaluation of this data to determine whether individuals who suffered a heart attack as a side effect of Ziagen, Trizivir, Epzicom, Kivexa, Videx or generic didanosine, may be entitled to compensation through an AIDS drug lawsuit. Any updates or additional information regarding the review of these drugs will be posted to this area of our site.
