BACKGROUND: Pai You Guo is a weight loss supplement manufactured in China and adulterated with the banned pharmaceutical products sibutramine and phenolphthalein. The US Food and Drug Administration (FDA) announced a voluntary recall of Pai You Guo in 2009, yet clinicians have noted its continued use among Brazilian-born women in Massachusetts. OBJECTIVE: To assess prevalence of Pai You Guo use, associated side effects, modes of acquisition, and impact of FDA regulatory action on these outcomes. DESIGN: Cross-sectional study using an anonymous questionnaire. PARTICIPANTS: Women ≤60 years of age, born in Brazil who attended one primary care clinic or one of six churches in Massachusetts. MAIN MEASURES: Prevalence of use, how users first heard about the product, location of purchase, associated side effects, patterns of use before and after the FDA recall. KEY RESULTS: Twenty-three percent (130/565) of respondents reported using Pai You Guo. In multivariate analysis, obesity (adj OR 3.7, p-value <0.001) and lack of insurance (adj OR 2.6, p-value 0.005) were associated with use. The majority of users (85%) reported at least one side effect. Dry mouth (59%), anxiety (29%), and insomnia (26%) were most commonly reported adverse effects. Nearly thirty-percent of users (38/130) purchased Pai You Guo from local stores and 9% (11/130) purchased it over the Internet. The majority of respondents (79/130; 61%) purchased Pai You Guo after the FDA recall. No respondent was aware of the FDA recall. CONCLUSIONS: Use of this pharmaceutically adulterated supplement is common among Brazilian-born women in Massachusetts. The FDA alerts and recall did not appear to decrease its use.
BACKGROUND:Pai You Guo is a weight loss supplement manufactured in China and adulterated with the banned pharmaceutical products sibutramine and phenolphthalein. The US Food and Drug Administration (FDA) announced a voluntary recall of Pai You Guo in 2009, yet clinicians have noted its continued use among Brazilian-born women in Massachusetts. OBJECTIVE: To assess prevalence of Pai You Guo use, associated side effects, modes of acquisition, and impact of FDA regulatory action on these outcomes. DESIGN: Cross-sectional study using an anonymous questionnaire. PARTICIPANTS: Women ≤60 years of age, born in Brazil who attended one primary care clinic or one of six churches in Massachusetts. MAIN MEASURES: Prevalence of use, how users first heard about the product, location of purchase, associated side effects, patterns of use before and after the FDA recall. KEY RESULTS: Twenty-three percent (130/565) of respondents reported using Pai You Guo. In multivariate analysis, obesity (adj OR 3.7, p-value <0.001) and lack of insurance (adj OR 2.6, p-value 0.005) were associated with use. The majority of users (85%) reported at least one side effect. Dry mouth (59%), anxiety (29%), and insomnia (26%) were most commonly reported adverse effects. Nearly thirty-percent of users (38/130) purchased Pai You Guo from local stores and 9% (11/130) purchased it over the Internet. The majority of respondents (79/130; 61%) purchased Pai You Guo after the FDA recall. No respondent was aware of the FDA recall. CONCLUSIONS: Use of this pharmaceutically adulterated supplement is common among Brazilian-born women in Massachusetts. The FDA alerts and recall did not appear to decrease its use.
Authors: W Philip T James; Ian D Caterson; Walmir Coutinho; Nick Finer; Luc F Van Gaal; Aldo P Maggioni; Christian Torp-Pedersen; Arya M Sharma; Gillian M Shepherd; Richard A Rode; Cheryl L Renz Journal: N Engl J Med Date: 2010-09-02 Impact factor: 91.245
Authors: Heidi Michels Blanck; Mary K Serdula; Cathleen Gillespie; Deborah A Galuska; Patricia A Sharpe; Joan M Conway; Laura Kettel Khan; Barbara E Ainsworth Journal: J Am Diet Assoc Date: 2007-03
Authors: Janine L Pillitteri; Saul Shiffman; Jeffrey M Rohay; Andrea M Harkins; Steven L Burton; Thomas A Wadden Journal: Obesity (Silver Spring) Date: 2008-01-24 Impact factor: 5.002