Use of a pharmaceutically adulterated dietary supplement, Pai You Guo, among Brazilian-born women in the United States.

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.