Better Safety Control of Dietary Supplements

United States Needs Better Safety Control Of Dietary Supplements

01/09/2003

By Harvey McConnell

There is an urgent need for detailed research into the medical risks posed by dietary supplements on sale in the United States.

A collaborative study involving investigators at poison centres, emergency rooms and universities across the US highlights a record of adverse events, including seizures, coma, myocardial infarction, arrhythmias, coagulation disorders, hepatic disease, anaphylaxis, and death.

The finding "underscores the need for greater knowledge of adverse events associated with dietary supplement use," says lead author Dr Susan Smolinske, Department of Emergency Medicine, Landspitali University Hospital, Reykjavík, Iceland.

There are an estimated 29,000 products on the market in the United States, the investigators point out, and there has been striking growth in supplement use over the past ten years. While it is known that some dietary supplements can have serious adverse effects, these can remain undetected by the medical community.

Dietary supplements do not have to undergo the mandatory surveillance required of prescription drugs, and there is no accessible and comprehensive register of supplement names and ingredients. The quantity and quality of rudimentary surveillance information compiled by the toxic exposure surveillance system of the American Association of Poison Control Centres (AAPCC) is inadequate, and they do not always detect adverse event signals.

Investigators found that only 36% of 1,232 dietary supplement products reported to poison control centres were listed in the commercial information database used by the poison centres, and less than half all adverse events related to dietary supplements were documented in any of the five information sources they consulted.

Multiple ingredients, long-term use, and the age of patients were all associated with increased severity of symptoms.

The investigators said that their research raises a number of concerns, ranging from the lack of child resistant, pre- and perinatal exposure, ingestion of multiple ingredients, to long-term consumption, and the quality of surveillance. There is a "need for a comprehensive register of dietary supplements, strengthened surveillance (particularly mandatory reporting of adverse events), enforceable definitions of what constitutes a risk to safety, and what circumstances warrant product recall.

"Safety research should become a priority in investigations of dietary supplements to clarify hazards and possible risks for this recently defined class of foods."

Lancet 2003;361:101-06.

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