In the dark about dangers
This article appeared in In March 2008, Marques Parke, 29, a plumber from Janesville, Wis., took a weight-loss supplement called Hydroxycut because he wanted to lose 5 pounds, he said. Within weeks he was stricken with acute hepatitis and jaundice. He is suing the manufacturer and others. An attorney representing the defendants said they intended to contest the claims.
The FDA had received its first adverse-event report about Hydroxycut in 2002, long before Parke started taking it. In May 2009, by which point Parke's liver was already damaged, the agency warned consumers to stop using Hydroxycut, and the manufacturer, Iovate Health Sciences, voluntarily recalled some of its products, its attorney said.
The company had frequently reformulated the product, according to the FDA, which said it didn't know which ingredients produced the liver toxicity. The FDA said that Hydroxycut presented "a severe, potentially life-threatening hazard to some users" and had been linked to two reported deaths. Hydroxycut has been reformulated and is on the market again. An FDA representative told us the agency considers the new version acceptable.
Amazingly, for the first 13 years after the enactment of the DSHEA, supplement makers didn't have to inform the FDA if they received reports of serious adverse events, an obligation that's required for prescription drugs. A law that took effect in December 2007 closed that loophole, and in 2008 and 2009 the FDA said it received 1,359 reports of serious adverse effects from manufacturers and 602 from consumers and health professionals. But even with the new law, consumers can't easily find out which products are involved because the FDA doesn't routinely make those reports available to the public.
