Dr. Robert Eckel, a University of Colorado medical school professor, said stronger heart failure warnings may be appropriate.
"The fact that the FDA has had to reach the stage of a black box means physicians may not be heeding the existing contraindications," Eckel, immediate past president of the American Heart Assn., said in an interview. "From the data we have, I think this risk of heart failure is the one that needs to be increasingly brought to the attention of physicians."
Takeda Pharmaceuticals, which manufactures Actos, said it had agreed in principle to the FDA's request.
A senior Glaxo official, research and development head Moncef Slaoui, declined to answer reporters' questions about his company's discussions with the FDA over the stronger warnings.
In written testimony, he told the committee that Glaxo is discussing ways to "further enhance the prominence" of heart failure warnings.
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ricardo.alonso-zaldivar@latimes.com
Times staff writer Karen Kaplan in Los Angeles contributed to this report.
