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Dietary Supplements & Liver Injury

A new study has linked dietary supplements to severe hepatic reactions including acute liver injury and other serious side effects.

A new study has linked a number of popular dietary supplements to adverse hepatic reactions including acute liver injury and other serious side effects. Significant injuries have been reported following the consumption of Herbalife and Hydroxycut products, green tea, supplements containing usnic acid and high contents of vitamin A, as well as in anabolic steroids and others. The side effects associated with these products vary widely from person to person, ranging from elevated serum liver enzymes to hepatic failure and even death.

Free Dietary Supplement Liver Injury Case Evaluation: If you or a loved one has suffered a serious liver injury after consuming dietary supplement products, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and we can help.

What’s the problem?

Over the past decade, the use of dietary supplements (DS) has become a major health trend in the United States and other affluent nations. Between 1999 and 2004, consumption of dietary supplements in the US doubled to nearly 20 percent of adults and upwards of 50 percent in certain subgroups such as among elderly, non-smoking females with higher education. This dramatic rise in popularity of dietary supplements can largely be attributed to an increased health conscious awareness and the desire to prevent diseases by optimal nutrition. As a result, the manufacturing and marketing of DS products has become a multibillion dollar business largely unregulated by the U.S. Food & Drug Administration (FDA).

In the United States, dietary supplements are expected to meet standards outlined in the Dietary Supplement and Health Education Act, which allows DS distribution without prior approval by the FDA. This controversial licensing practice does not ensure efficacy and safety in the same strict way as with the approval process of conventional drugs. The reckless approval of dietary supplements is made even more troubling by the fact that DS may harbor specific problems because of their complex composition, particularly with respect to quality aspects.

While a number of side effects associated with dietary supplements have been well documented, the issues at hand are still not clearly understood due to widespread and uncontrolled use, as well as by the under-reporting of side effects. Making matters worse, a low public awareness regarding the risk of DS products impedes their recognition as the causative agent in incidents of hepatoxicity. Consequently, statistics involving dietary supplement side effects are likely inaccurate and too low.

Dietary Supplement Liver Injury Case Study

A recent article published in the Official Journal of the International Association for the Study of the Liver has reviewed the current medical literature on liver injuries associated with dietary supplements in order to identify the mechanisms of injury and to increase public awareness of the risks posed by these popular products.

In February 2010, case reports on liver injury occurring following the consumption of dietary supplements published between 1990 and 2010 were searched in PubMed and EMBASE databases and critically reviewed. Products were considered dietary supplements if they were intended to be consumed to improve nutrition, lose weight, or to treat constipation. While hepatoxicity from DS has been addressed in previous case studies, there were few if any summaries devoted specifically to liver-related risks. The new article, which is titled ‘Review of liver injury associated with dietary supplements,’ reviewed a panel of best-selling dietary supplements that have been associated with acute liver injury.

Herbalife Liver Injury Side Effects

Herbalife sells a variety of dietary supplement products for weight control, nutrition, ‘well-being’ and cosmetics. In 2006, it was reported that the company generated $3.1 billion in profits via online marketing and independently operating sales agents.

Since 2007, there have been six published reports on liver damage following the consumption of Herbalife products. Cumulatively, the reports described 34 cases from five countries – Switzerland, Israel, Spain, Argentina and Iceland. The pattern of injury was mostly hepatocellular, but mixed and cholestatic enzyme patterns were also observed. Severity of side effects ranged from mild to severe hepatic damage, including cirrhosis and acute liver failure requiring liver transplantation.

It still remains unclear what might have caused the liver damage in these cases, as patients took up to 17 different Herbalife products at the same time, making it extremely difficult if not impossible to identify the critical compound(s). Moreover, speculations flew over potentially adultered Herbalife products after two patients demonstrated bacterial contamination as a possible explanation of liver injury. Herbalife has numerous manufacturing facilities worldwide, suggesting that contaminated products either intentionally added during the manufacturing process or accidentally contained in the unrefined raw products could have been responsible for the reports of hepatoxicity.

Green Tea (Camellia Sinensis)

Green tea is among the most popular dietary supplement drinks in the United States today. The first incidence of liver injury associated with green tea was reported in 1999, and since then, a rash of similar cases have been reported to regulatory agencies worldwide. In response, a number of green tea manufacturers have recalled their products from their respective markets.

The US Pharmacopeia performed a systemic review of all cases accessible from PubMed, EMBASE and various pharmacovigilance databases, and found a strong causal relationship between observed liver injuries and green tea consumption. The mode of toxicity derived from green tea still remains incompletely understood, but experimental studies have demonstrated both hepatoprotective as well as hepatotoxic properties.

‘Whether the risks from green tea consumption outweigh their benefits remains open, but current evidence as outlined above suggests a causal relationship between intake of green tea containing products and hepatoxicity.’

Hydroxycut Liver Injuries

Hydroxycut is designed to support weight loss, and is sold in powder, capsule, and tablet formulations. Several Hydroxycut drugs have recently been recalled by Lovate Health Sciences following a May 2009 warning issued by the FDA citing 23 reports of severe liver injury associated with the products. Lovate has been charged previously with several lawsuits for unfounded health claims.

Before 2009, Hydroxycut’s main ingredients included Garcinia cambogia, Gymnema sylvestre, chromium polynicotinate, caffeine and green tea. Published cases were recently reviewed and showed acute onset of liver injuries after several weeks of Hydroxycut intake.

Although its exact frequency remains unclear, hepatic injury secondary to consumption of dietary supplements like Herbalife, green tea and Hydroxycut is recognized. Apart from enhanced diagnostic measures, better regulatory steps to assure efficacy are required. Efforts of pharmacovigilance authorities and healthcare providers must act jointly to minimize risks and protect the public. Perhaps most importantly, consumers should develop a more critical attitude toward the expectations and hopes associated with dietary supplement use, and turn to measures for which safety data are known and efficacy is proven.

Do You Have a Dietary Supplement Liver Injury Lawsuit?

The Product Liability & Defective Drug Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in dietary supplement liver injury lawsuits. We are handling individual litigation nationwide and currently accepting new dietary supplement liver injury cases in all 50 states.

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