AUDIENCE: Consumer, Pharmacy
ISSUE: FDA warned consumers and healthcare professionals that Que She, marketed as an herbal weight loss supplement, contains unlisted and active pharmaceutical ingredients that could harm consumers, especially those with cardiovascular conditions. These active pharmaceutical ingredients also may interact with other medications and result in a serious adverse event.
BACKGROUND: Que She, advertised as Ã¢??Slimming Factor CapsuleÃ¢? and as Ã¢??an all-natural blend of Chinese herbs,Ã¢? has been widely distributed on Internet sites such as the Bouncing Bear Botanicals website, and at retail outlets, including Sacred Journey in Lawrence, Kansas.
FDA analysis of Que She found that it contains:
- fenfluramine Ã¢?? a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage
- propranolol Ã¢?? a prescription beta blocker drug that can pose a risk to people with bronchial asthma and certain heart conditions
- sibutramine Ã¢?? a controlled substance and prescription weight loss drug, sibutramine 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
- ephedrine Ã¢?? 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.
RECOMMENDATIONS: People who have purchased Que She should stop taking the product immediately and consult a health care professional.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
[07/08/2010 - News Release - FDA]