Tuesday, September 23, 2008

Dietary supplements cause 600 'adverse events'

Side effects from the use of food supplements resulted in 604 "adverse-event" reports — a list that includes at least five deaths — through the first six months that such accounts have been required by law. The Office of Nutritional Products, Labeling and Dietary Supplements in the Food and Drug Administration's Center for Food Safety and Applied Nutrition acknowledged receiving 368 mandatory reports from supplement manufacturers and 236 reports from consumers or health care professionals. 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. "Some of these deaths were likely due to underlying medical conditions," he says.

If the trend continues, there will be fewer than the 960 adverse-event reports the FDA had estimated it would receive each year. "These numbers don't alarm us," says Steve Mister, president and chief executive of the supplement trade group Council for Responsible Nutrition. "We thought they would be much less than the FDA estimate."

For perspective, the FDA took in 482,154 adverse-event reports for prescription drugs last year.

Bonnie - we applauded the AER bill when it was passed and it seems to be accomplishing its purpose. While the low numbers exhibit the overall safety of dietary supplements, it also proves the point that taking them should be overseen by a health professional. However, for people to put them in the same category as drugs is preposterous. And if "concern that a med is not working" was added to the adverse-events report for meds is listed, the 482,154 number would triple.

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