On May 1, 2009, the US Food and Drug Administration (FDA) issued a press release urging consumers to stop using 14 varieties of the diet aid Hydroxycut and return unused portions to the place of purchase. The FDA also sent a letter to health care professionals stating that officials “believe [Hydroxycut] presents a serious public health risk.” In response, the manufacturer of Hydroxycut, Iovate Health Sciences, Inc., decided to issue a voluntary recall of all products named by the FDA. But just how dangerous is Hydroxycut, really? Was the FDA justified in its action, or is this an overhasty response to a minor health concern.
About Hydroxycut Injuries
The main rationale for the FDA’s action regarding Hydroxycut is liver damage. In some patients it seems to create acute liver toxicity that required hospitalization in more than 2/3 of the reported cases, and required liver transplants for two of them. One of the patients was deemed unsuitable for a liver transplant because of significant damage to other organs. This patient, a 17-year old male, had taken an elevated dose of Hydroxycut, and died after the decision was made not to pursue the liver transplant.
In addition to liver damage, the FDA determined that a number of serious illnesses have been associated with Hydroxycut use, including cardiovascular injury, seizures, and severe muscle damage known as rhabdomyolysis.
The Numbers of Hydroxycut Injuries
In its press releases and statements, the FDA claims there have been 23 cases of confirmed liver damage resulting from the use of Hydroxycut. The cases appeared over a seven year period. With millions of bottles of Hydroxycut being sold every year, the number of injuries may seem very small, making many believe that FDA’s statement and subsequent recall is something of an overreaction.
The Rationale for the Hydroxycut Action
Hydroxycut seems to cause what is known as idiosyncratic liver toxicity, a condition which is inherently very rare. The toxic reaction occurs in less than 10 people per 100,000, and often in less than 1 per 100,000. Although toxic reactions are rare, idiosyncratic liver toxicity is the most common form of drug-induced liver toxicity because it is unpredictable, generally undetected in clinical trials, and often occurs with only recommended doses of a drug.
In addition, the FDA did not know what ingredient of Hydroxycut was responsible for the liver toxicity. It did not know whether liver toxicity was the result of a biologic extract or a heavy metal. It did not even know whether the toxicity may have been the result of contaminated or badly blended pills. Reports of liver damage have been associated with Hydroxycut since its introduction, but it was believed at first that the ingredient ephedra, associated with seizure, cardiovascular damage, and other adverse health effects, was responsible for the damage. But Hydroxycut has been ephedra-free since the ingredient was banned in 2004, and reports of liver damage have continued.
Because of all the unknowns, the FDA could not issue a specific caution that would identify users with an elevated risk from Hydroxycut and thereby reduce future cases of liver toxicity. The only way the FDA could protect users was to ask them to stop using Hydroxycut, a request that will likely stay in effect until a causative agent can be identified.
So, How Dangerous Is Hydroxycut?
We’re back to the place we started then, with the question of how dangerous is this diet aid? The answer is: no-one knows. The FDA’s action is designed to stop more people from suffering adverse, potentially deadly reactions to Hydroxycut while the agency and the manufacturer of the supplement determine what is the cause. Once the ingredient responsible has been identified, we can expect Hydroxycut to return to the market either reformulated or with specific warnings that may help users make informed decisions about whether a diet supplement with no proven effectiveness is worth the potential risk.
