The FDA has recalled 14 Hydroxycut weight loss supplements after receiving reports of severe liver damage that led to the death of a 19-year-old man, and a liver transplant in another supplement user, as well as reports of jaundice and liver enzyme elevation. 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. Other adverse events include seizures, cardiovascular disorders, and rhabdomyolysis, a serious type of muscle damage. The supplement manufacturers, Iovate Health Sciences USA of Blasdell, N.Y., and Iovate Health Sciences of Oakville, Ontario, in Canada, have agreed to voluntarily cooperate with the FDA.
The death occurred in 2007, but the FDA did not learn of it until March, 2009, a delay that is not unusual given that supplement manufacturers are subject only to voluntary, not mandatory, reporting of adverse events. And, unlike drug manufacturers who must follow strict disclosure regulations regarding active ingredients, supplement manufacturers are not required to disclose precise ingredients to the FDA, but can hide behind the "proprietary blend" rubric. This makes it especially difficult for the agency to identify the toxic substances causing the adverse events. The FDA was unable to identify the precise substance believed to be at work here, but the pattern of injury suggests that adverse events may occur regardless of dosage or the length of use of the product.
The surprise here is not that untested diet supplements can cause hepatotoxicity, even at recommended doses, or that there is no free lunch in the world of weight loss supplements. The surprise is that Hydroxycut is still in business. Remember its tattered history of using ephedra in its products, using deceptive before and after photographs, and falsely claiming that it had scientific data of its product's effectiveness (when, in fact, study participants were dropping out due to adverse events and the company replaced them with new study participants). The surprise is that our current regulatory scheme has allowed the company to remain in business at all.
FDA: News Release--5/1/09
Medical Literature: Hydroxycut hepatotoxicity: A case series and review of liver toxicity from herbal weight loss supplements, World J Gastroenterol 2008 December 7; 14(45): 6999-7004; Hepatotoxicity associated with weight loss supplements: A case for better post-marketing surveillance; World J Gastroenterol 2009 April 14; 15(14): 1786-1787.
New York Times: Studies of Dietary Supplements Come Under Growing Scrutiny, 6/23/03