A 23-year-old man fell ill and was treated in a hospital in Sydney for an inflamed liver after taking the controversial dietary supplement, said the Sydney Morning Herald. According to the man’s physicians, he was the "first reported Australian case of acute hepatotoxicity associated with the weight-loss product Hydroxycut Hardcore," quoted the Sydney Morning Herald. "... We advise medical practitioners and consumers in this country to be wary of the product and call on the TGA to re-examine its continued availability," wrote doctors N. Nudrat Rashid, of the Royal Prince Alfred Hospital, and Jason Grant of Ryde Hospital, according to the paper.
The patient said that he did not exceed Hydroxycut’s recommended dosage and was taking the supplement over a 10-week period, reported the Sydney Morning Herald. When he reached the hospital, he was jaundiced and complained of lethargy, said the Sydney Morning Herald, citing paperwork published in the Medical Journal of Australia (MJA). "Results of the patient's liver biopsy showed severe acute hepatitis," the doctors wrote, quoted the Sydney Morning Herald. He stopped taking Hydroxycut and ultimately recovered, but was hospitalized for eight days, added the Sydney Morning Herald.
In the United States, noted the Sydney Morning Herald, there have been a number of reported illnesses and, sadly, one death. The U.S. Food and Drug Administration (FDA) ordered a recall after receiving 23 reports of serious liver problems in people who used the products, including one in which liver damage was so serious a transplant was needed and another in which a 20-year-old died. There have also been reports linking Hydroxycut products to seizures; cardiac problems; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
"Consumers should seek medical advice if they develop any symptoms suggestive of liver disease such as jaundice (yellowing of the skin) and are encouraged to report such events to the TGA," a TGA spokeswoman said. "The TGA will be following up the case with the authors of the article to identify the product and the exact nature of the adverse event," quoted the Sydney Morning Herald.
In the U.S., a Hydroxycut recall prompted advocacy group Reality Coalition to urge Congress to reform a law governing dietary supplement regulation. The Dietary Supplement Health and Education Act (DSHEA) does little to protect consumers from unsafe supplements like Hydroxycut until it’s too late because, under DSHEA, supplement makers don’t need to seek product pre-market approval unless the product contains a “new dietary ingredient.” The FDA lacks authority to evaluate claims made on supplements’ labels; only the Federal Trade Commission is authorized to do so. Unfortunately, because of current DSHEA provisions, the FDA and the public do not become aware of side effects or dangerous, undeclared ingredients until a product has been on the market for some time, sometimes following injuries and fatalities. According to Reality Coalition, tragedies like those linked to Hydroxycut will continue until DSHEA is reformed.
To compound the situation, said Bruce Silverglade, director of legal affairs for the Center for Science in the Public Interest, “They don’t work…. Nothing burns fat. Nothing makes you lose weight while you sleep. These are known false claims,” the Atlanta Journal-Constitution quoted.
Last week, the Food & Drug Administration (FDA) ordered the Hydroxycut recall after it had received 23 reports of serious liver problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant, linked to use of Hydroxycut products. In one case, a 20-year-old died as a result of Hydroxycut-associated liver damage..
The agency had also received reports linking Hydroxycut products to seizures, cardiac problems, and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
Under DSHEA, supplement makers don't need to seek premarket approval of products unless they contain a "new dietary ingredient." Only then must they complete a premarket review of safety data, which typically involves clinical trials. As a result, the side effects of a supplement product usually are not apparent until it has been on the market for a while, and if users report adverse event to the FDA.
Under DSHEA, the FDA also lacks the authority to evaluate claims made on supplements' labels. Only the Federal Trade Commission is authorized to do so.
Unfortunately, the vast majority of consumers are unaware that the FDA has so little muscle when it comes to regulating supplements. According to a Reality Coalition survey, 54% of patients think such products are FDA approved for safety, and 46% think they're approved for efficacy.
As Reality Coalition points out, the Hydroxycut recall is only the latest incident to highlight the inadequacies of DSHEA. For instance, in 2004 the FDA banned the ingredient ephedra in supplements after thousands of people using such products reported liver problems and other toxic events. Ephedra was linked to fatalities, including that of a Baltimore Orioles pitcher Steve Bechler.
Recently, the FDA has gotten more aggressive in policing dietary supplements - especially in regards to undeclared ingredients. In March, the agency sent letters to 72 companies regarding such ingredients, and many of the companies subsequently recalled their products.
Unfortunately, because of the current provisions of DSHEA, the FDA and the public do not become aware of either side effects or dangerous, undeclared ingredients until a product has been on the market for sometime - and possibly injures many consumers. According to Reality Coalition, tragedies like those linked to Hydroxycut will continue to occur until DSHEA is reformed.
"Now is the ideal time for Congress . . . to raise the regulatory bar for weight loss supplement manufacturers to be accountable for the safety and efficacy of their products," Louis J. Aronne, M.D., co-chair of Reality Coalition, said in a statement. "We firmly believe that there needs to be an FDA review process for all over-the-counter weight loss products."The Monster the movie
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According to an FDA safety alert issued last Friday, there have been 23 reports of serious liver problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant, linked to use of Hydroxycut products. In one case, a 19-year-old died as a result of Hydroxycut-associated liver damage. That death occurred in 2007, but was only reported to the agency in March.
The incidents prompted the FDA to order a recall of 14 Hydroxycut supplements, and the agency also warned consumers to stop using them immediately.
According to the FASEB Journal, the Hydroxycut recall is similar to another issued for StarCaps supplements. Before they were recalled, StarCaps were advertised as containing a "mix of the digestive enzyme in the papaya and the diuretic qualities in the garlic [that] result in weight loss for users." Advertisements for StarCaps also touted the herbal ingredient, valerian, as a stress reliever and diuretic.
The StarCaps supplements are the subject of a false advertising class action lawsuit filed by an NFL football player. Last year, several NFL players blamed StarCaps supplements when they failed urinary steroid tests and faced four-game suspensions. According to the players, the maker of StarCaps deceptively laced the product with bumetanide, a diuretic banned by the NFL. According to the FASEB editorial, bumetanide will produce false positives in urine steroid tests.
In addition to failing to mention that StarCaps contained bumetanide, labeling for the supplements "failed to note that papain is an effective protease that can be absorbed topically, that valerian has proven soporific effects in humans, and that the magnesium salts contained in the capsule affect the gut," the FASEB editorial said.
A month after the StarCaps lawsuit was filed, the FDA ordered the supplements recalled. According to the agency, bumetanide was found in the supplements at levels of 0.8 mg/capsule. Shortly thereafter, the FDA ordered a recall of 60 weight-loss supplements that were found to contain sibutramine (a centrally acting, serotonin-norepinephrine reuptake inhibitor), rimonabant (a cannabinoid receptor antagonist), phenytoin (better known as dilantin), and phenolphthalein (a pH indicator and laxative, banned in the United States as a carcinogen).
Supplements like Hydroxycut and StarCaps are allowed to endanger the public because the FDA has no authority to order premarket testing of such products. In fact, according to the FASEB editorial, since 1994,the FDA has had no effective regulatory authority over dietary supplements, unless they cause harm or are doped with prescription drugs. Thus, as in the case of Hydroxycut, such products can harm dozens of people before they are removed from the market.
"You don't need to be a pharmacologist to suspect that almost anything that really affects the structure or function of the human body might have an unwanted side effect (a.k.a., toxicity)," the editorial writer states. "Indeed, a search in PubMed for 'herbal drugs/toxic effects' finds such 460 articles...These range from hepatotoxicity from herbals and weight-loss supplements in the United States to kidney failure as a result of aristolochia, a Chinese herb used worldwide."
The editorial makes a compelling case for more rigorous oversight of dietary supplements, pointing out that "unregulated drugs that have tangible personal and professional consequences that go well beyond anything described on their labels."
According to the FDA safety alert issued on Friday, there have been 23 reports of serious liver problems ranging from jaundice and elevated liver enzymes, an indicator of potential liver injury, to liver damage requiring liver transplant, linked to use of Hydroxycut products. In one case, a 20-year-old died as a result of Hydroxycut-associated liver damage in 2007.
The patients involved in the adverse event reports were otherwise healthy and their symptoms began after they started using Hydroxycut, the agency said. Many also became sick despite correctly following directions on the Hydroxycut label for recommended dosage.
In addition to liver problems, the FDA said on Friday it had also received reports of Hydroxycut users suffering seizures, cardiac problems, and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
According to a report from the FDA's Health Hazard Evaluations Board, the first report of liver damage linked to Hydroxycut was recorded in 2002. According to the FDA, it took the agency 7 years to spot the supplements' risk because such problems are rare. But critics of the agency point out that the FDA has no authority to review dietary supplements like Hydroxycut before they're marketed. According to the Associated Press, the FDA relies on voluntary reports to detect problems with supplements after they come to market, and many cases are never reported.
Meanwhile, the FDA has not been able to say which ingredients in Hydroxycut products might be causing the liver problems and other side effects. According to the agency, that's because the combination of ingredients used in Hydroxycut has changed over the years.
According to the Associated Press, one possible suspect is an ingredient derived from tropical fruit called hydroxycitric acid. One public health researcher told the Associated Press that at least one medical journal article has linked hydroxycitric acid to liver damage. The same expert also cautioned that other diet products that contain hydroxycitric acid are probably still on the market.
Hydroxycut products are dietary supplements that are marketed for weight-loss, as fat burners, as energy-enhancers, as low carb diet aids, and for water loss under the Iovate and MuscleTech brand names. The products contain a variety of ingredients and herbal extracts. Hydroxycut products are made by Iovate Health Sciences Inc., of Oakville, Ontario and distributed by Iovate Health Sciences USA Inc. of Blasdell, N.Y.
The FDA has 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. One death due to liver failure has been reported to the FDA. Other health problems associated with the recalled Hydroxycut products include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
Liver injury, although rare, was reported by patients at the doses of Hydroxycut recommended on the bottle. Symptoms of liver injury include jaundice (yellowing of the skin or whites of the eyes) and brown urine. Other symptoms include nausea, vomiting, light-colored stools, excessive fatigue, weakness, stomach or abdominal pain, itching, and loss of appetite.
Consumers should consult a physician or other health care professional if they are experiencing symptoms possibly associated with these products.
The Hydroxycut products associated with this recall include:
* Hydroxycut Regular Rapid Release Caplets
* Hydroxycut Caffeine-Free Rapid Release Caplets
* Hydroxycut Hardcore Liquid Caplets
* Hydroxycut Max Liquid Caplets
* Hydroxycut Regular Drink Packets
* Hydroxycut Caffeine-Free Drink Packets
* Hydroxycut Hardcore Drink Packets (Ignition Stix)
* Hydroxycut Max Drink Packets
* Hydroxycut Liquid Shots
* Hydroxycut Hardcore RTDs (Ready-to-Drink)
* Hydroxycut Max Aqua Shed
* Hydroxycut 24
* Hydroxycut Carb Control
* Hydroxycut Natural
Not all of these products have been associated with side effect reports, the FDA said. However, Iovate has agreed to recall all the products listed above. Hydroxycut Cleanse and Hoodia products are not affected by the recall.