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Weight Loss Supplements: Warning List Grows

In 2004 the FDA banned the sale of any dietary supplement that contained the ingredient ephedra, citing concerns that “the increased risk of heart problems and strokes negates any benefits of weight loss.

Consumers continue, however, to gobble up weight loss supplements at an astounding rate. According to a New York Times article, Americans spent an estimated $25 billion on weight loss products last year.

Weight Loss Supplement Issue Puts Pressure on FDA

As the weight loss industry explodes, the number of unregulated and potentially dangerous dietary products is forcing the FDA to increase it’s efforts to protect consumers. While the Government Accountability Office (GAO) acknowledged in a report this year that the FDA has been working to watchdog the supplement industry more closely, the GAO report indicated that the agency is still falling short.

In the first 10 months last year, the FDA received 948 reports of health issues related to supplements, including 9 deaths and 234 hospitalizations. The problem may be staggering considering how many cases likely go unreported. The FDA estimates that over 50,000 health problems are associated with the use of diet supplements each year.

The list of dangerous dietary products with active, unregulated ingredients is growing. On Dec. 22, 2008, the FDA warned the public against purchasing or consuming 28 different weight loss products that contained undeclared, active pharmaceutical ingredients. As of Jan. 8, 2009, the list grew to include 41 additional products. As of March 2009 the FDA’s Initiative Against Contaminated Weight Loss Products website listed 72 weight loss products consumers should avoid, including three additional weight loss products, Herbal Xenicol, Slimbionic, and Xsvelten and four new undeclared active pharmaceutical ingredients, fenproporex, fluoxetine, furosemide, and cetilistat.

Diet Pills: Ingredients to Avoid

The flagged products contain active, unregulated ingredients or prescription drugs at levels that exceed maximum recommended dosages. Manufacturers may claim their products are “natural” or contain only “herbal” ingredients, but they may contain harmful ingredients they aren’t included on the product label or in their promotional advertisements.

According to the FDA, the following active ingredients included in some weight loss supplements pose serious health risks:

  • Sibutramine, a prescription-only appetite suppressant that is also a controlled substance. It was found in many of these products at high levels that can increase the incidence and severity of the listed health risks.
  • Fenproporex, a controlled substance that is not approved for marketing in the United States. It can cause arrhythmia (a disorder of your heart rate or rhythm) and possible sudden death.
  • Fluoxetine, a prescription-only antidepressant.
  • Bumetanide and furosemide, potent diuretics (drugs that increase the production of urine) available by prescription only.
  • Cetilistat, an experimental obesity drug not approved for marketing in the United States.
  • Phenytoin, a prescription-only anti-seizure medication.
  • Phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States.

The full list of dangers associated with each ingredient are included on the FDA website. Some potential risks include:

  • high blood pressure
  • seizures
  • rapid heartbeat
  • palpitations
  • heart attack
  • stroke

Hydroxycut Recall Highlights Dangers of Diet Pill Ingredients

While the FDA continued to flag diet products contaminated with unregulated and potentially harmful ingredients, the popular dietary aid Hydroxycut made news after the agency received 23 reports of serious health problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant.

In May 2009 the manufacturer of Hydroxycut voluntarily recalled fourteen of their products and the FDA warned consumers to immediately stop using all Hydroxycut products. The agency has not been able to pinpoint which ingredients, dosages, or other factors are toxic and caused the health problems because the Hydroxycut products contain a variety of ingredients and herbal extracts

Public health researcher Ano Lobb has studied Hydroxycut and other dietary supplements for Consumer Reports says the problem may be due to an ingredient called hydroxycitric acid. Hydroxycitric is derived from a tropical fruit and has been linked to liver problems in at least one medical journal study. Lobb said other supplements containing the same ingredient likely remain on the market.

Dr. Linda Katz of the FDA’s food and nutrition division told the Associated Press (AP) it takes time to assess the Hydroxycut issue because the FDA has no authority to review supplements before they’re marketed. “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow,” said Katz.

Diet Pill Dangers: How Consumers Can Protect Themselves

Health care professionals and consumers should report serious side effects or product quality problems to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail, fax or phone.

“You really have to be careful about dietary supplements, especially weight-loss pills,” Lobb told the AP. “People believe that the FDA has verified that these products are at least safe and effective, and that’s really not the case. When you see fantastic claims—that’s generally what they are.”

While consumers continue to look for a magic pill to lose weight, the FDA is increasing it’s efforts to monitor the dietary supplement industry to the degree their limited oversight allows. In the meantime, the FDA warns consumers to be wary of over-hyped weight loss product claims such as promises of “miraculous cures,” “secret ingredients,” or claims that a product is completely safe because it’s “all natural.”

Additional Information:

To receive FDA recalls, market withdrawals and safety alerts: http://www.fda.gov/Safety/Recalls/default.htm

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Footnotes:

Singer, Natasha, “Study Urges More Oversight of Dietary Items,” The New York Times, March 3, 2009.

“Government Report Calls for More Supervision of Diet Supplements,” Diets in Review.com, March 6th,2009.

Doheny, Kathleen, “Hydroxycut Recall Due to Liver Injuries,” WebMD, May 1, 2009.

“FDA recalls Hydroxycut supplements after reports of liver damage,” ConsumerReports.org, May 1, 2009.

“FDA warns dieters: Stop Hydroxycut use now,” Associated Press. MSNBC.MSN.com, May 1. 2009.

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