FDA Adverse Event Reports
Posted Tuesday, September 23, 2008

USA Today, the most widely circulated English language newspaper in the world, reported yesterday that there were 604 adverse event notices connected to dietary supplements in the first half of 2008, as reported by the FDA. This is the first time reporting adverse events has mandated by the FDA, which instituted a new law that required the reports last year. 368 of the notifications came from supplement manufacturers, and 236 from consumers or health care providers. From USA Today:

An adverse event can be anything from a concern that a supplement isn't working to a serious illness that follows consumption. FDA spokesman Michael Herndon said five deaths and 85 hospitalizations were reported through April 15, the most current numbers available. "Some of these deaths were likely due to underlying medical conditions."

What the article does not address at length however, is the fact that the FDA took in 450,000 adverse event reports about pharmaceutical drug cases in the last year, a fact discussed in a recent news release by NutraUSA. This is quite the discrepancy, to say the least.

USA Today does go on to mention that the number of events noted so far this year is far fewer than was initially expected. The numbers are well within the predicted range, and what is more, compared with pharma-drugs, they are looking really rather exceptional, as was noted by Daniel Fabricant, vice president of scientific and regulatory affairs of the Natural Products Association. He went on to say:

“NPA was a big supporter of the law and played a pivotal role in its passage. We most certainly believe the law is doing what it was intended to do: protect the consumer. And we believe it is bearing out what we’ve said along, that dietary supplements are an overwhelming safe consumer product. This is especially true when judged against the same reporting standards used for prescription medications, medical devices and over-the-counter drugs."

To have a look for yourself, here are the two different ways of reporting on such a story:
Nutra USA "AERS: supplements 604 - drugs 450,000
USA Today "Dietary supplements cause 600 'adverse events'"

*Private comment posted* @ 4:41:45 pm

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