Dr. John Jenkins, the director of the FDA's Office of New Drugs, says that among the agency's top concerns are the cardiovascular risks associated with many drugs aimed at treating chronic conditions, like pain and diabetes. He gave examples of meds now known to have serious cardiovascular side effects, including GlaxoSmithKline's diabetes medication, Avandia; Novartis' bowel med, Zelnorm; and Merck's off-the-market pain drug, Vioxx.
Today, more and more patients take medications for chronic conditions. At the same time, the incidence of cardiovascular disease in the general population is high and rising. Therefore, teasing out the intricacies of which medications lead to increased heart risks is complicated.
As a result, the agency is changing how it will consider new medicines, Jenkins said, adding that this is the "the biggest safety shift in the last few years," as well as "a driver for a lot of the public concern about drug safety."
Patients take many medications indefinitely, and Jenkins said that FDA will consider which of these would need additional research into cardiovascular side effects. Of priority are medications for chronic conditions like diabetes and high cholesterol, where the conditions themselves increase the risk of heart problems. Approved medications might also have more stringent research and data requirements.
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