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Both mandatoiy and voluntary dietary supplement adverse event reports (currently the 3500A and 3500 forms, respectively) may now be submitted.
Since licensed in October 2009, VAERS has received 3 adverse event reports occurring in the US following Cervarix.
The Food and Drug Administration's Center for Devices and Radiological Health fails to use adverse event reports in a systematic manner to detect and address medical device safety problems, a report from the HHS Office of the Inspector General found.
Under two proposed rules issued in August, manufacturers and other facilities that are currently required to submit adverse event reports to the FDA would have to begin doing so "in an electronic format that the FDA can process, review, and archive.
Adverse event reports generally only represent from 1 percent to 10 percent of actual incidence, so the number of hypersensitivity reactions and deaths is likely significantly higher, the researchers said.
Most of the adverse event reports to VAERS were consistent with pre-licensure trial data.
The submission of adverse event reports is essential for CDRH to be able to identify existing and potential risk factors of medical devices.
s Adverse Event Reporting System indicated that Coumadin[R] is among the top 10 drugs with the largest number of serious adverse event reports submitted from the 1990's to the present.
In calendar year 2004, FDA received 422,500 adverse event reports.
What took FDA so long in the case of ephedra is that FDA has the burden of proving that a supplement poses a significant or unreasonable risk before it can take action [to restrict its use]," she says--an extremely difficult case to make in the absence of adverse event reports.
Reid said manufacturers, distributors, hospitals and doctors file about 300,000 adverse event reports with FDA yearly.
Adverse event reports generally are not sufficient on their own to establish that reported problems are caused by the use of a particular product, but can signal potential health problems that deserve investigation.
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