FDA Panel: Keep Avandia on Market

Two U.S. drug-safety officials Monday said GlaxoSmithKline PLC’s diabetes drug Avandia should be pulled from the U.S. market.

Food and Drug Administration drug-safety reviewer David Graham said at an advisory panel meeting of outside medical experts that Avandia increases cardiovascular risk compared to its non-use and that rival drug Actos does not increase cardiovascular risk, The Wall Street Journal reported.

Actos is marketed in the United States by Takeda Pharmaceuticals North America Inc.

Graham said that Avandia also has no unique short-term benefits or demonstrated long-term health benefits and should be removed from the market.

Graham’s boss, Gerald Dal Pan, told the panel he agreed Avandia should be taken off the market.

But Robert Meyer, a director in the FDA’s office of new drug evaluation, said agency officials were split on how to handle Avandia and he had not decided if the drug should be pulled.

Glaxo said there was no consistent or systematic evidence the drug raises the risk of heart attack or cardiovascular risk.

None of these drugs are perfect, Glaxo Senior Vice President and Chief Medical Officer said. Avandia is an important option.