Archives: FDA's safety messages are incomplete

FDA's safety-alert system isn't doing its job. That's what a new Archives of Internal Medicine article contends: The agency's monitoring of its adverse-events database--and publicizing early findings--has yielded some drug-label changes, the Archives article says. But most of those changes didn't include advice about what to do next.

As The New York Times reports, a 2007 law requires the FDA to monitor its adverse-events database and issue quarterly reports on what it finds. About half of the FDA's "safety signals" ended up triggering a label change. "At best, healthcare providers should be looking at alternative therapies if serious potential risks are present," the Archives piece states (as quoted by the NYT). "The FDA should consider changing the statements ... to better reflect the significance of potential safety signals."

For its part, the FDA said recommending alternative treatments can be problematic, especially if the so-called safety signal inspires the agency to ask for more analysis or additional drug studies. "Efforts to enhance drug safety and surveillance and analysis are under way," two CDER officials wrote for Archives.

- read the NYT piece

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