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Banned Weight Loss Supplement Still in Use
Even though it was recalled by the FDA in 2009, many women in the United States continue to use Pai You Guo, a Chinese weight-loss supplement, despite the dangers. Why? A new study reveals that many women never heard about the recall.
Pai You Guo contains a combination of banned pharmaceutical products – sibutramine and phenolphthalein. Sibutramine was the active ingredient in Meridia, a weight-loss drug that was recalled by the FDA because it increased the risk of heart attack and stroke. Phenolphthalein was an ingredient once found in over-the-counter laxatives until it was labeled as a potential carcinogen. Both of these ingredients are banned in the United States.
The study, conducted in Boston by Harvard Medical School researchers, surveyed over 550 females who were born in Brazil and live in the greater Boston area. Alternative diet products are popular in this community. The researchers found that 23% of the women said they had used Pai You Guo and 61% purchased the dietary supplement after the FDA recall. None of the Brazilian women in the study were aware of the recall.
The side effects of Pai You Guo include dry mouth, anxiety, insomnia, heart palpitations, depression, fainting, nausea, and vomiting. Eighty-five percent of respondents said they experienced at least one of these side effects.
Where did the women purchase the banned supplement? Sixty-six percent of the women reported getting it from an acquaintance in the U.S., 30% purchased it from a store in this country, and 9% reported purchasing the supplement online. The product is sold in stores alongside other traditional Chinese herbs and spices like ginseng and shark's fin. It is marketed as a natural way to lose weight, even though it is a mixture of banned drugs.
There is a misconception among consumers that if a product is labeled "natural," it must be safe to use. And that isn't necessarily true. The researchers warned that people should not use any type of dietary supplement that claims to help shed pounds. The regulations in the United States aren't strong enough to prevent dangerous products from reaching consumers. Even when products are known to be dangerous, the FDA does not have the ability to remove them from store shelves.
Consumers who are looking for a quick and easy way to lose weight often fall victim to products that promise quick , easy, and magical weight loss results. According to Michael Levy, director of the FDA's Division of New Drugs and Labeling Compliance, "These products are not legal dietary supplements. They are actually very powerful drugs masquerading as 'all-natural' or 'herbal' supplements, and they carry significant risks to unsuspecting consumers."
The FDA has found other weight-loss products marketed as supplements that are actually dangerous combinations of pharmaceuticals including seizure medications, blood pressure medications, and other drugs not approved in the United States. The FDA website provides information and advice on weight-loss dietary supplements for consumers.
This study was published online in the Journal of General Internal Medicine in advance of appearing in the upcoming print issue.
September 17, 2011