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Researchers warn of hazards of inadequately regulated dietary supplements

Posted 15 Jan 2024

After a review of several databases, researchers with Touro College of Pharmacy and Nova Southeastern University’s College of Pharmacy have identified a total of 79,071 reported adverse events related to the use of dietary supplements. The events were reported to U.S. Food and Drug Administration’s (FDA) Center for Food Safety and Applied Nutrition (CFSAN) between 2004 and 2021. Their searches for adverse-event reports included the use of vitamin E (vitamin derivative), beta-sitosterol (plant sterol) yohimbine, kava kava, kratom, garcinia cambogia, herbal products, and OxyElite Pro (marketed for weight loss).

Key points made in their paper include:

  • Vitamin E supplementation has documented interaction with several routine medications.
  • Over a thousand adverse events regarding the use of a prostate support supplement called Super Beta Prostate containing beta-sitosterol were reported to CFSAN in the past two decades. Most of the reports involved finding blood in the urine.
  • Poison centers
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Experts spotlight liver injury from herbal dietary supplements in the U.S

Posted 19 April 2023

Experts on natural products and toxicology have provided an overview of the problem of liver damage due to herbal dietary supplement (HDS) use in the United States. They suggest two strategies they hope will improve consumer safety and drive bad actors from the marketplace. One is a path for pre-clinical assessment and the other is the establishment of a list of products.
Reference: Gurley BJ, and others. Hepatoxicity due to herbal dietary supplements: Past, present, and the future. Food and Chemical Toxicology 169:113445, 2022

Their key points include:

  • The Dietary Supplement Health and Education Act of 1994 provides an insufficient framework for regulating HDS products.
  • 20% of adult Americans regularly consume HDS products.
  • Liver toxicity is among the most frequent serious events reported through the U.S. Food and Drug Administration’s Center for Food Safety and Applied Nutrition Adverse Event Reporting System.
  • 20% of all drug-induced
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Drug-related liver injury: call for better regulation of supplements

Posted 26 July 2021

Medical Journal Australia – InSight 

DOCTORS at a Sydney liver transplant centre have raised concerns about the rising rate of drug-induced liver injury (DILI) cases linked to herbal and dietary supplements, warning these cases are often at the severest end of the spectrum.

Paracetamol remains the drug most commonly linked to DILI, a study of DILI cases at Royal Prince Alfred Hospital’s AW Morrow Gastroenterology and Liver Centre found.

There were 115 paracetamol-related cases and 69 non-paracetamol related cases at the centre over the 12 years to 2020. Of the non-paracetamol DILI cases, antibiotics and antifungals were the most commonly implicated medicines (19 cases). However, the proportion of cases linked with herbal and dietary supplements (15 cases) grew steadily over the period, from 15% to 47% of the non-paracetamol cases.

Cases linked with herbal or dietary supplements had especially poor prognoses, the study found, with 90-day … Read the rest

Evidence lacking for “alternative” weight-loss therapies

Posted 07 July 2021

A systematic review of published research evaluating the efficacy of dietary supplements and “alternative therapies” for weight loss among people at least 18 years of age has found that supportive evidence is weak. Many clinical trials were also hampered by a significant risk of bias due to inconsistent testing methods. Problems with studies include small sample sizes, short follow-up periods, and poor study designs.
Reference: Batsis JA. A systematic review of dietary supplements and alternative therapies for weight loss. Obesity, June 23, 2021

Key findings included:

  • Out of 315 randomized controlled trials included in the review, 52 were classified as having a low risk of bias, of which 16 demonstrated significant weight changes for tested therapies compared to placebo.
  • No high-quality evidence supported acupuncture, calcium-vitamin D supplementation, chocolate/cocoa, phenylpropanolamineguar gumPhaseolus vulgarispyruvate, and mind-body interventions as weight-loss
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Science Has Shown These Five Weight Loss Supplements Are a Waste of Money

Posted 11 December 2019

By Clare Collins, Lee Ashton & Rebecca Williams

The Conversation 8 Dec 2019

When you google “weight loss” the challenge to sort fact from fiction begins.

These five supplements claim to speed up weight loss, but let’s see what the evidence says.

1. Raspberry ketones

Raspberry ketones, sold as weight loss tablets, are chemicals found in red raspberries responsible for that distinct raspberry flavour and smell. You can also make raspberry ketones in a lab.

A study in obese rats found raspberry ketones reduced their total body fat content.

In one study, 70 adults with obesity were put on a weight loss diet and exercise program, and randomised to take a supplement containing either raspberry ketones, or other supplements such as caffeine or garlic, or a placebo.

Only 45 participants completed the study. The 27 who took a supplement lost about 1.9 kilos, compared Read the rest

5 supplements that claim to speed up weight loss – and what the science says

Posted 31 January 2018

From The Conversation

When you google “weight loss” the challenge to sort fact from fiction begins. These five supplements claim to speed up weight loss, but let’s see what the evidence says (for raspberry ketones, Matcha green tea powder, Garcinia cambogia supplements, caffeine supplements, and alkaline water)

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Is Garcinia a safe and effective dietary supplement for patients hoping to lose weight?

Posted 03 December 2017

Garcinia became a rock star in the dietary supplement world after a 2012 endorsement by television host Dr Mehmet Oz, who called it a “revolutionary fat buster.” (The endorsement was removed from the Dr Oz website following a USA Senate hearing on questionable weight loss products.)

This opinion by a pharmacist who is an Assistant Professor, Department of Physiological Sciences, Eastern Virginia Medical School in the USA, and published in Medscape, concludes that “Currently, not enough research is available to recommend garcinia or HCA-containing products for weight loss”.

 Note, dosage is important and her conclusions need to be read with this in mind for many products use even less than the dose studied.

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Garcinia Linked to Liver Damage

Posted 28 April 2017

Garcinia is found in a number of USN and Herbex products, as well as other weight-loss products. This abstract from Natural Medicines, Integrative Medicine Newsletter of 25 April 2017, points out the risks of liver damage.

Garcinia contains the constituent hydroxycitric acid (HCA) which is purported to have a role in weight loss. Taking garcinia extract in doses providing up to 2800 mg of HCA daily has been used with apparent safety for up to 12 weeks; however, there is concern about liver damage. There are several case reports of liver toxicity in people who have taken garcinia alone or in combination with other ingredients for as little as one week. It’s unclear if garcinia is the actual cause of liver problems in these reports or if it is due to other factors.

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Liver failure and transplant needed after supplement use

Posted 06 April 2016

According to a new report, a 26-year-old otherwise healthy Australian man required a liver transplantation following the use of two dietary supplements. The patient had taken a whey protein powder containing green tea and many other ingredients, as well as a weight loss supplement containing 70% Garcinia cambogia for one week. Analytic testing did not identify any contaminants.

In 2009, there were at least 40 cases of liver injury in the U.S. following the use of Hydroxycut weight loss products. The formulation of Hydroxycut products varied, but most of those associated with liver problems contained Garcinia cambogia and green tea. The Norwegian food safety authority has also issued a warning about green tea extract supplements following multiple reports of liver damage.

Reference:
Smith RJ, Bertilone C, Robertson AG. Fulminant liver failure and transplantation after use of dietary supplements. Med J Aust. 2016 Jan 18;204(1):30-2… Read the rest

Diet supplements threat to liver

Posted 25 January 2016

From the Medical Journal Australia:

CLINICIANS have been warned to be alert to the possible role of herbal and dietary supplements in cases of hepatotoxicity in the wake of a West Australian man experiencing severe drug-induced liver injury (DILI) after taking a protein and weight loss supplement.

A case report published in the Medical Journal of Australia outlined the experience of a 26-year-old Indigenous man who presented with severe liver injury 10 weeks after taking a whey protein supplement containing green tea extract as well as a dietary supplement containing Garcinia cambogia for just 1 week. The researchers reported that the patient had no previous medical history, did not drink to excess, was not taking medications regularly, and did not smoke or use illicit substances.

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