FDA issues warning about Que She weight-loss supplement
SILVER SPRING, Md. The Food and Drug Administration on Thursday warned that Que She, marketed as an herbal weight-loss supplement, actually is an adulterated drug product as it contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions.
People who have purchased Que She should stop taking the product immediately and consult a healthcare professional.
Que She, advertised as "Slimming Factor Capsule" and as "an all-natural blend of Chinese herbs," has been widely distributed on such Internet sites as the Bouncing Bear Botanicals website, and at such retail outlets as Sacred Journey in Lawrence, Kan.
An FDA analysis of Que She found that it contained fenfluramine, a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage; propranolol, a prescription beta-blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions; sibutramine, a controlled substance and prescription weight-loss drug, which was the subject of a recent study whose preliminary findings showed an association between sibutramine use and increased risk of heart attack and stroke in patients who have a history of heart disease; and ephedrine, a stimulant drug that is legally marketed over-the-counter for temporary relief of asthma but can pose a risk to people with certain cardiovascular conditions.
These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.
Consumers and healthcare professionals are encouraged to report adverse events related to the use of Que She to the FDA's MedWatch Safety Information and Adverse Event Reporting Program: online at FDA.gov/MedWatch/report.htm; by phone at (800) FDA-1088, or (800) 332-1088; or, by returning FDA form 3500, available on the MedWatch "Download Forms" page by mail to the address on the pre-addressed form or by fax at (800) FDA-0178.