Dietary Supplements Responsible for Over 600 Adverse Events

Over 600 serious adverse reactions have been reported in those who use dietary supplements, including five deaths. These reports were received in the first six months that such accounts have been required by law.

The Office of Nutritional Products, Labeling, and Dietary Supplements, which is part of the Food and Drug Administration's (FDA) Center for Food Safety and Applied Nutrition, said that it received 368 mandatory reports from supplement manufacturers and 236 reports from consumers or health care providers. FDA spokesman Michael Herndon said that five deaths and 85 hospitalizations were reported through April 15, which are the most recent numbers available.

The FDA has not identified the particular supplements linked to the adverse side effects. The agency defines dietary supplements as including vitamins, minerals, amino acids, enzyme supplements, and herbs or botanicals.

Consumer advocates have long been critical of the fact that supplement manufacturers don't have to prove that their products are safe or effective before they are put on the market. Sen. Richard Durbin, D-Ill., sponsored legislation in 2006 to require supplement makers to inform the FDA when there are adverse reactions to their products. The bill became effective on January 1, 2008.

"Five years ago, the dietary supplement industry claimed that they had no reports of health problems – zero – related to their products," Durbin said. "Thanks in part to our legislation, we today know there are hundreds of serious problems each year, many involving hospitalization and death," he says.

If the current trend continues, there will be fewer than the 960 annual adverse-event reports than the FDA had estimated. "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."

Sen. Durbin pushed the dietary supplement legislation came after several deaths related to the now-banned supplement ephedra. The energy and weight loss enhancer was implicated in the deaths of Minnesota Vikings offensive lineman Korey Stringer in 2001 and Baltimore Orioles pitcher Steve Bechler in 2003.

"There's still no assurance that supplements are safe," says Peter Lurie, deputy director of Public Citizen's Health Research Group. "Many people are under the impression that the FDA has approved supplements, but that's not the case. There's really no assurance that what manufacturers say is in the product is really in there."

Adverse-event reporting has been mandatory for prescription and some non-prescription drugs for years. The FDA received 482,154 adverse-event reports for prescription drugs last year.

Source: "Dietary supplements cause 600 'adverse events'." USA Today. September 23, 2008.