Que She Herbal Supplement Has It All: Undeclared Drug Ingredients Fenfluramine, Propranolol, Sibutramine, Ephedrine

Last Updated on July 11, 2010 by Joseph Gut – thasso

July 11, 2010 – Do the people behind such products at all know what they do?

On July 08, 2010, the FDA has issued the following warning concerning the Que She Herbal Supplement and its Undeclared Drug Ingredients:

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 “Slimming Factor Capsule” and as “an all-natural blend of Chinese herbs,” 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  • Fenfluramine – a stimulant drug withdrawn from the U.S. market in 1997 after studies demonstrated that it caused serious heart valve damage;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.

    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 Online Reporting Program at www.fda.gov/MedWatch/report.htm. Other avenues of reporting also exist.

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    Ph.D.; Professor in Pharmacology and Toxicology. Senior expert in theragenomic and personalized medicine and individualized drug safety. Senior expert in pharmaco- and toxicogenetics. Senior expert in human safety of drugs, chemicals, environmental pollutants, and dietary ingredients.