The FDA reported that it has received 23 reports of liver problems with people taking Hydroxycut products. Because the FDA relies on voluntary reports to detect problems with dietary supplements, the FDA reporting system typically learns of only a small fraction of the injuries in these types of cases, so the number of injuries is likely to be substantially higher.How Serious Are the Reports of Injury from Hydroxycut?
Hydroxycut is the suspect in a death of a teenage boy, according to the FDA. Other patients experienced symptoms ranging from jaundice, or yellowing of the skin, to liver failure. One user of Hydroxycut received a transplant and another was placed on a waiting list for a new liver. There is not definitive “proof” that Hydroxycut was the cause, but the patients were reportedly otherwise healthy and their symptoms began after they started using Hydroxycut.What is Hydroxycut?
Hydroxycut is the brand name of 90% of weight loss drugs that have been taken by millions of consumers. Hydroxycut, which was sold at GNC, the Vitamin Shoppe, and even grocery stores, was packaged in different ways: pills, drinks and powders. The purpose of Hydroxycut was to increase energy, burn calories and fat, and control appetite. Unlike pharmaceutical drugs and medical devices, which require a showing of safety and effectiveness data before receiving federal approval to sell the products, dietary supplements do not need F.D.A. approval to go on sale. Manufacturers of dietary supplements are responsible for ensuring and documenting the safety and efficacy of their supplements without federal approval. Many have criticized how easy it is to get drugs and devices approved by the FDA even though they lack the safety data proving the safety of the drug or device. Multiply that concern by 1000 and you have the situation we have with supplements in this country. It is the Wild West. Hydroxycut reportedly did/does help you lose weight, although that evidence is mostly anecdotal because the FDA requires so little data from supplement manufacturers. Hydroxycut also has a lot of caffeine (a powerful stimulant and appetite suppressant) which might explain why users have reported weight loss while taking Hydroxycut. (One of the lawyers in our office purchased Hydroxycut, but never used the product; one of our paralegals took the product for years.)Which Products are Covered by this Voluntary Recall?
The following products are covered by this voluntary recall:
- Hydroxycut Regular Rapid Release Caplets
- Hydroxycut Caffeine-Free Drink Packets
- Hydroxycut Hardcore Drink Packets (Ignition Stix)
- Hydroxycut Max Drink Packets
- Hydroxycut Liquid Shots
- Hydroxycut 24
- Hydroxycut Carb Control
- Hydroxycut Hardcore RTDs (Ready-to-Drink)
- Hydroxycut Max Aqua Shed
- Hydroxycut Caffeine-Free Rapid Release Caplets
- Hydroxycut Hardcore Liquid Capsules
- Hydroxycut Max Liquid Capsules Hydroxycut Regular Drink Packets
- Hydroxycut Natural
Two other products, Hydroxycut Cleanse and Hydroxycut Hoodia, with different ingredients, are not affected by the recall.Is There Speculation as to Why Hydroxycut Can Cause Liver Injury?
No one knows for certain why Hydroxycut would cause liver failure or jaundice. But there is concern about excessive use of hydroxycitric acid, which is derived from a tropic fruit. While harmless in the quantities you might get eating fruit, Hydroxycut may cause a hydroxycitric acid overdose, causing liver damage. Symptoms include:
- Abdominal pain
- Brown urine
- Liver damage
- Cardiovascular disorders
Hydroxycut users have suffered seizures, cardiovascular disorders, and rhabdomyolysis, a severe form of muscle damage that can lead to kidney failure.