GSK HIV drug poses no increased heart attack risk, FDA says

GlaxoSmithKline‘s HIV drug abacavir does not increase the risk of a heart attack, according to results of a new safety review by the U.S. Food and Drug Administration.

Abacavir is an antiviral medication that is used in combination with other antiretroviral drugs to treat HIV infections. Medications on the market that contain abacavir include Ziagen, Trizivir and Epzicom. Those products combined generated more than $1.3 billion in 2009 revenue for GSK (NYSE:GSK). London-based GSK has its U.S. headquarters in Research Triangle Park, North Carolina.

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The FDA in 2008 issued an alert about abacavir regarding serious and sometimes fatal hypersensitivity reactions associated with the drug. The FDA said this week that there has been conflicting information on the potential increased risk of heart attack with abacavir. An increased cardiac risk was seen in several observational studies and one randomized controlled trial with abacavir. But the FDA said an increased risk of heart attack has not been seen in other randomized controlled trials, or in the safety database maintained by GSK. The FDA reviewed 26 randomized clinical trials evaluating abacavir.

The abacavir announcement is good news for GSK. Cardiac risks linked to the company’s former blockbuster drug Avandia doomed that product and the company now faces lawsuits from thousands of patients or their families claiming injury or death from the drug.