Drugs' heart risk is FDA worries about the rise of serious heart risks
The rise of serious heart risks in drugs that treat chronic conditions has become one of the U.S. Food and Drug Administration's top worries and is changing how the agency weighs new medicines.
The agency is thinking about how to weigh such possible side effects as more drugs that treat diabetes, pain and other conditions also appear linked to heart attacks and other complications, said Dr. John Jenkins, director of the FDA's Office of New Drugs.
"That has been the biggest safety shift in the last few years, and it's also, I think, a driver for a lot of the public concern about drug safety," he said. "We are thinking about what the implications of these new data and these new findings are for all chronically-used drugs," he said.
The agency has already said that it plans to give specific advice to drug makers about what kinds of data they will need to sell diabetes drugs in the United States.
Source: InterMedia consulting
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