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, a top FDA official said on Tuesday.
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, Dr. John Jenkins, director of the FDA's Office of New Drugs, told the Reuters Health Summit in New York.
"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.
The FDA's recommendation, or guidelines, will be released "very soon," Jenkins said.
In July, an FDA panel of outside advisers said companies should have to conduct long-term studies of cardiovascular effects or provide equivalent evidence to rule out an "unacceptable" risk of heart problems.
Source
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, Dr. John Jenkins, director of the FDA's Office of New Drugs, told the Reuters Health Summit in New York.
"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.
The FDA's recommendation, or guidelines, will be released "very soon," Jenkins said.
In July, an FDA panel of outside advisers said companies should have to conduct long-term studies of cardiovascular effects or provide equivalent evidence to rule out an "unacceptable" risk of heart problems.
Source
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