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Before the 2004 reformulation, formulations contained ephedra, a supplement banned by the FDA in 2004. Before the 2009 reformulation, formulations contained several substances with potential to harm the liver. After a series of reports in the medical literature of serious liver problems, including one death, the FDA warned consumers to stop using Hydroxycut, and Iovate agreed to voluntarily recall the products.
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In March 2013, Sean Lowe became the brand ambassador for Hydroxycut Hardcore. In the same month, IndyCar racer Tony Kanaan announced he will pilot the No. 11 Hydroxycut IndyCar at the Indianapolis 500 along with 8 other events at the 2013 IndyCar Championship. Hydroxycut has been promoted as being created and endorsed by doctors. Television advertisements for Hydroxycut featured a medical resident, although reporters were unable to locate him after Hydroxycut was removed from the market in 2009.
Prior to 2004, some formulations of Hydroxycut contained ephedra. There were reports of seizures in people who had ingested Hydroxycut, which were attributed to the ephedra and caffeine in the product. As a result, there were around 80 pending ephedra lawsuits against MuscleTech.
In 2003, Missouri Attorney General Jay Nixon filed a lawsuit in St. Louis against Hydroxycut's manufacturer, MuscleTech, stating that its marketing claims that Hydroxycut was "clinically proven" to be a "fat-burner" were false. Nixon also alleged that "MuscleTech's own consultants had serious concerns about the safety of Hydroxycut, but the company continued to market the product." MuscleTech paid $100,000 to settle the case and agreed to cease marketing ephedra-containing products in Missouri and to refund customers' money.
The New York Times reported in 2003 that internal documents from MuscleTech indicated that the company had buried studies showing that Hydroxycut was ineffective, covered up evidence of cardiac side effects, and even tampered with the documents it submitted as evidence in a lawsuit in Oklahoma.
In 2004, the FDA banned ephedra after 155 deaths from heart attack and stroke were attributed to ephedra, including the death of Baltimore Orioles pitcher Steve Bechler. It was the first banning of a dietary supplement by the FDA.
On May 1, 2009, the U.S. Food and Drug Administration (FDA) issued a warning to consumers to stop using Hydroxycut products, due to 23 reports of serious health problems associated with the use of Hydroxycut, and at least one death, and to destroy any product that they may possess. The warning stated "Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk. Consumers who have these products are urged to stop using them." Following the FDA warning, the manufacturer then agreed to voluntarily recall the products.
In October 2020, 6ix9ine was reportedly hospitalized after having an overdose from mixing two Hydroxycut diet pills with a McDonald's McCafé coffee. He has claimed that he came to weigh more than 200 lbs after leaving prison but has said that using the medication had helped him shed 30 lbs since he was released. His lawyer denies the overdose claim.
While some diet supplement executives defended the safety of Hydroxycut and believed the media "over-hyped" the FDA withdrawal, others questioned why Iovate had not published long-term safety or efficacy studies on the final Hydroxycut products, and used weak trial duration and sample sizes. This is despite having the money to perform such studies and their self-definition as a "research-oriented" company. The editors of the nutrition trade journal Nutrition Business Journal noted that this recall "will ultimately be a good thing for the dietary supplement industry if it encourages weight-loss supplement manufacturers to care as much about their products' safety and efficacy as they do about expanding and protecting their bottom lines."
The plant ephedra (ma huang) contains multiple chemical compounds, but the most notable is ephedrine. This molecule impacts several bodily processes and was used as a popular dietary supplement ingredient prior to being banned in several countries.
Ephedrine, a major component of ephedra, can increase the number of calories your body burns. Research has shown this results in greater weight and fat loss over weeks to months, though long-term studies are limited.
While some individual studies did not demonstrate serious side effects of ephedra or ephedrine consumption, mild to highly concerning side effects became apparent upon examination of all available research.
Dietary supplements containing ephedrine alkaloids were banned by the FDA in 2004. Medications containing ephedrine and the ephedra plant are still available for purchase, though regulations may vary by location.
Hydroxycut has been associated with at least 50 instances of clinically apparent acute liver injury, but the specific Hydroxycut product implicated in different cases has varied and the specific ingredients responsible for liver injury remain unclear. In reported cases, the onset of injury was generally within 2 to 12 weeks of starting regular use. The typical presenting symptoms were fatigue, nausea, and abdominal pain followed by dark urine and jaundice. The pattern of liver injury was hepatocellular with serum aminotransferase levels as high as several thousand U/L, while alkaline phosphatase levels tended to be normal or minimally elevated (less than 3 times ULN). Liver biopsies showed an acute hepatitis-like picture, and severe cases were associated with confluent, submassive or massive necrosis. Immunoallergic and features were not common although autoantibodies were detected in a proportion of cases. The mortality rate overall was approximately 10% among cases with jaundice. In nonfatal cases, symptoms resolved within 1 to 8 weeks and laboratory tests return to normal within two to three months. The phenotype associated with Hydroxycut products was clearly an acute, self-limited viral hepatitis-like syndrome. Nevertheless, rare instances of cholestatic or mixed hepatitis with prolonged jaundice have also been reported in patients taking Hydroxycut products.
The cause of acute liver injury associated with Hydroxycut products was attributed to ephedra in the past and more recently to green tea extract (Camellia sinensis). Indeed, the clinical features of cases resemble those associated with the liver injury associated with green tea extracts. Green tea is rich in catechins, antioxidants that are oxidized by the fermentation processes that yield black tea. The most active catechin is epigallocatechin 3-gallate (EGCG), which is believed to be responsible for the antioxidant activity of green tea extract. In high doses, catechins and specifically EGCG causes acute hepatocellular injury in mice and rats, but the equivalent dose in humans (30-90 mcg/kg) is considerably higher than is usually administered in typical weight loss products (3-12 mg/kg). However, environmental and host factors may alter susceptibility to catechin injury, such as nutritional status, obesity, fasting and antioxidant status including hepatic glutathionine levels. This explanation of liver injury, however, does not explain recent cases of liver injury attributed to Hydroxycut cases, as the product now does not generally contain green tea extract (at least according to the product labels).
The acute hepatic injury associated with Hydroxycut exposure is usually self-limiting and resolves within 1 to 3 months. There is no evidence that corticosteroids are beneficial. Fatal cases of liver injury have been reported with Hydroxycut use. There is little information or cross reactivity to other weight loss products, but avoidance of green tea extract containing supplements is prudent. It is important to report cases of liver injury associated with HDS use and it is helpful to retrieve the actual product being used to verify the name, manufacturer and lot number as well as for possible future toxicologic analysis.
A 27 year old man developed fatigue and jaundice 4 to 5 weeks after starting Hydroxycut (9 tablets per day) for weight loss. He denied previous liver disease, alcohol abuse, recent travel or risk factors for viral hepatitis. He denied taking any other medications or herbal preparations. Laboratory tests showed serum bilirubin of 7.8 mg/dL and marked elevations in serum aminotransferase levels (ALT 3131 U/L, AST 1808 U/L), with minimal increases in alkaline phosphatase (171 U/L) (Table). Liver tests worsened for a day and then rapidly improved.
Green tea hepatotoxicity typically presents with jaundice and an acute viral hepatitis-like syndrome, and a markedly hepatocellular pattern of serum enzyme elevations and rapid improvement upon stopping. Hydroxycut contains high concentrations of green tea extract, although formulations frequently change. Because Hydroxycut, like many dietary supplements, is a brand of many products with many ingredients, it is difficult to implicate a specific ingredient of the product as the cause for liver injury. Other listed components of Hydroxycut products currently include calcium, chromium, potassium Garcinia cambogia, Gymnema sylvestre leaf extract, glucomannan, alpha-lipoic acid, willow bark extract, L-carnitine, caffeine, guarana extract, gelatin, silica and cellulose. The product implicated in this report from 2005, however, may have had other components including ephedra and green tea.
Jacquelyn has been a writer and research analyst in the health and pharmaceutical space since she graduated with a degree in biology from Cornell University. A native of Long Island, NY, she moved to San Francisco after college, and then took a brief hiatus to travel the world. In 2015, Jacquelyn relocated from sunny California to even sunnier Gainesville, FL, where she owns 7 acres and more than 100 fruit trees. She loves chocolate, pizza, hiking, yoga, soccer, and Brazilian capoeira. Connect with her on LinkedIn. 041b061a72