FDA Reports Lower Supplement AERs Than Expected

The U.S. Food and Drug Administration (FDA) has lowered its official estimate for adverse event reports (AERs) potentially connected to dietary supplements, from 960 to 856 following lower-than-expected actual reports through April. Reporting of “serious” AERs became mandatory for dietary supplement manufacturers with the passage of legislation in late 2006. The Natural Products Association has reported extensively on the legislation, and information regarding it can be found at http://www.naturalproductsassoc.org/AER.

But despite the fact that the number of adverse events is actually lower than expected, one news report, in USA Today , has already appeared that paints a negative picture by not putting the information in context and burying important facts.

In looking at the number of AERs that have been reported, it is important to remember three key points:

Adverse events are not necessarily causal. In other words, they may not actually be connected to the adverse health condition reported. The FDA must investigate and determine whether the problem reported is in fact connected to the dietary supplement taken, and whether it meets the definition for “serious.” (see definition below)

Usually, according to the FDA, an underlying medical problem also exists. Most adverse events reported are by people who were already ill, and also taking prescription or over-the-counter drugs.

The FDA is estimating that for the first six months of 2008 there will be 604 adverse events reported. To put this number in perspective, the FDA received more than 450,000 adverse event reports for prescription drugs last year.
A serious adverse event is defined as one that results in death, a life-threatening experience, inpatient hospitalization, significant disability or incapacity, or congenital anomaly or birth defect, or one that requires medical intervention to prevent one of the outcomes.

The report was published in the September 15, 2008 edition of the Federal Register, the federal government’s daily publication for rules, proposed rules, and notices.

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