Following the death of a 19-year-old male and 23 reports of liver damage, the FDA has stepped in to warn consumers to discontinue use of the popular diet pill Hydroxycut. Hydroxycut manufacturer Iovate Health Sciences has agreed to recall 14 products from the market as “an abundance of caution.”
From the FDA press release — 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 reported include seizures; cardiovascular disorders; and rhabdomyolysis, a type of muscle damage that can lead to other serious health problems such as kidney failure.
The teen’s death happened in 2007, and was only reported to the FDA in March 2009. Dr. Linda Katz of the FDA’s food and nutrition division said it has taken so long to bring this to the public’s attention because the cases were rare and the FDA has no authority over supplements (a government report in March 2009 called for higher supervision of supplements by the FDA). “Part of the problem is that the FDA looks at dietary supplements from a post-market perspective, and an isolated incident is often difficult to follow,” she said.
The FDA does not regulate supplements with the same authority it does pharmaceuticals. Producers do not have to have an FDA approval nor inspection of the products for safety or efficacy before being sold to consumers. “You really have to be careful about dietary supplements, especially weight-loss pills,” said Ano Lobb, who has studied Hydroxycut for Consumer Reports. “People believe that the FDA has verified that these products are at least safe and effective, and that’s really not the case. When you see fantastic claims — that’s generally what they are.”
The FDA does monitor aftermarket reports for health problems related to these supplements. A similar warning in 2004 regarding ephedra forced the government to enact a ban on the supplement ingredient following reports of heart attack and stroke.
This list of Hydroxycut products being recalled 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 Carb Control
Hydroxycut Cleanse and Hoodia products are not affected by the recall.
“The agency has not yet determined which ingredients, dosages, or other health-related factors may be associated with risks related to these Hydroxycut products. The products contain a variety of ingredients and herbal extracts,” per the FDA press release.
May 1st, 2009