Alerts
Pai You Guo Dietary Supplement Contains Undeclared Sibutramine and Phenolphthalein
November 13, 2009
FDA has discovered that Pai You Guo contains sibutramine, a prescription appetite suppressant, and phenolphthalein, an unapproved product suspected of causing cancer. GMP Herbal Products is recalling all lots of this product. The affected product was packaged as capsules in 30-count boxes and as powder in a 10-gram bag, and was distributed throughout the US.
Sibutramine is a controlled substance with the potential for abuse and addiction. Sibutramine has been associated with increased heart rate and blood pressure in some patients. These side effects may pose a risk to patients with a history of arrhythmia, stroke, congestive heart failure, or coronary artery disease.
Phenolphthalein solution is used for chemical experiments. Phenolphthalein is an unapproved drug which had been available in over-the-counter laxative products. In 1999, FDA banned the use of phenolphthalein in humans based on animal studies suggesting a potential for increased risk of cancer.
Educate patients to stop using Pai You Guo and contact their primary caregiver with any concerns. Patients may destroy the product or contact GMP Herbal Products at 866-995-8585 Tuesday through Saturday from 11AM to 7PM with any questions about returns.
Additional information is available at the following links:
- MedWatch Alert:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm190531.htm - Company Press Release:
http://www.fda.gov/Safety/Recalls/ucm190403.htm - FDA Questions and Answers about FDA’s Initiative against Contaminated Weight Loss Products:
http://www.fda.gov/Drugs/ResourcesForYou/Consumers/QuestionsAnswers/ucm136187.htm
Updated
November 13, 2009; University of Utah, Drug Information Service. Copyright 2009, Drug Information Service, University of Utah, Salt Lake City, UT.
