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Two Years After Recall, Dangerous Diet Supplement Still Available

Despite a recall in 2009 of the weight loss supplement Pai You Guo, a significant amount of people continue to take the product that contains not only banned pharmaceuticals, but a carcinogenic drug. The recall was announced by the U.S. Food and Drug Administration (FDA), which also issued alerts about the supplement’s risks, said Fox […]

Despite a recall in 2009 of the weight loss supplement Pai You Guo, a significant amount of people continue to take the product that contains not only banned pharmaceuticals, but a carcinogenic drug. The recall was announced by the U.S. Food and Drug Administration (FDA), which also issued alerts about the supplement’s risks, said Fox News.

In 2009, we wrote that an FDA lab analyses of dietary supplements distributed by GMP Herbal Products—maker of Pai You Guo—found them to contain two undeclared ingredients: Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.

A recent study revealed that almost 25 percent of Brazilian born women surveyed in Boston take Pai You Guo; none had knowledge of the recall, said Fox News. The findings, said study researcher Dr. Pieter Cohen, an assistant professor of medicine at Harvard Medical School and a general internist at Cambridge Health Alliance, point to the very serious issue in which dietary supplement regulation in the U.S. is inadequate.

“Even when the FDA clearly determines that there’s a hazardous product,” the agency is incapable of effectively removing it from the market, Cohen said, reported Fox News. Cohen also noted that the amount of banned drugs in the supplements “convinces us that this was no error” by the manufacturer, reported Fox News. “I do not believe that it’s safe to purchase weight loss supplements in the United States at this time,” Cohen added.

The researchers surveyed over 500 Boston area women who were born in Brazil because that demographic is known to use diet pills, said Fox News. Of the women, 23 percent used Pai You Guo in pill or capsule form; 85 percent reported a side effect such as dry mouth, anxiety, and insomnia. Most had bought Pai You Guo after it was recalled.

Since 2005, the agency has identified over 300 weight loss supplements containing banned drugs, which is probably only a small amount of the true number of adulterated supplement products making their way into U.S. shelves, said Cohen. In this case, said Cohen, the supplement is taken with the belief it is a natural product. “Instead, they’re consuming banned pharmaceutical product,” Cohen said, reported Fox News.

Because Pai You Guo has been sold in California, Florida, and Washington state, it is believed the issue is much larger than what was seen in the Boston sample. “We’re talking about a national problem,” Cohen said, according to Fox News.

In this case, not only is sibutramine not listed on the banned supplement label, some capsules and teas tested contained doses of the drug in excess of six times that found in prescription medications, said Cohen, wrote Fox News. As we’ve long mentioned, sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.

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