The U.S. Food and Drug Administration today published a warning about a product called "Que She," which is marketed as an herbal weight loss supplement. The capsules contains active pharmaceutical ingredients not listed on the product label that could harm consumers, especially those with cardiovascular conditions, government officials said.
People who have purchased Que She should stop taking the product immediately and consult a health care professional.
Que She, advertised as "Slimming Factor Capsule" and as "an all-natural blend of Chinese herbs," has been widely distributed on Internet sites, such as Bouncing Bear Botanicals, and at retail outlets.
An FDA analysis of Que She found that it contains a number of potentially harmful ingredients. Those include:
- fenfluramine - a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage.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, 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 - 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 health care professionals are encouraged to report adverse events related to the use of Que She at www.fda.gov/MedWatch/report.htm; by phone at 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.