As a cautionary measure, U.S. government health officials urged body builders and dieters to immediately cease ingesting 14 popular Hydroxycut products.
Touted as derived from natural ingredients, the Canadian made supplement is used by those hoping to drop pounds and body builders desiring improved muscle tone and definition. Readily available in grocery stores and pharmacies, at least nine million packages were sold in the U.S. last year, according to the FDA.
Recently, Hydroxycut has been associated with serious liver damage and one known death, a 19-year-old boy living in the Southwest who died in 2007 but not reported to the FDA until March of this year.
However, Dr. Linda Katz of the agency’s food and nutrition division said they have received 23 reports of serious liver problems including jaundice (yellowing of the skin or whites of the eyes), elevated liver enzymes, liver failure, a transplant, and one patient waitlisted for a new liver.
Other reported health concerns include cardiovascular disorders; seizures; and rhabdomyolysis, a type of muscle damage that can precede other serious health issues such as kidney failure.
Surprisingly, the FDA says the liver injuries did not appear to be the result of overdose. Their information came from the involved patients who claimed they adhered to the recommended dose on the Hydroxycut bottle.
The agency warned users of these products to seek medical attention if they experience any of the following conditions: jaundice, nausea, vomiting, light-colored stools, brown urine, excessive fatigue, weakness, itching, loss of appetite, and stomach or abdominal pain.
Although Hydroxycut Cleanse and Hoodia products are not affected, Iovate Health Sciences Inc., of Oakville, Ontario, has agreed to recall the following:
~Hydroxycut Regular Rapid Release Caplets
~Hydroxycut Caffeine-Free Rapid Release Caplets
~Hydroxycut Hardcore Liquid Caplets
~Hydroxycut Max Liquid Caplets
~Hydroxycut Regular Drink Packets
~Hydroxycut Hardcore Drink Packets (Ignition Stix)
~Hydroxycut Caffeine-Free Drink Packets
~Hydroxycut Max Drink Packets
~Hydroxycut Liquid Shots
~Hydroxycut Hardcore RTD (Ready-to-Drink)
~Hydroxycut Max Aqua Shed
~Hydroxycut Carb Control
Hydroxycut stated on their website, May 1, that the recall was voluntary. “While this is a small number of reports relative to the many millions of people who have used Hydroxycut products over the years, out of an abundance of caution and because consumer safety is our top priority, we are voluntarily recalling these Hydroxycut-branded products,” the statement said.
Again, but as always, this is a situation of consumer beware. Our government does not regulate dietary supplements as rigidly as medications. Appallingly, manufacturers need not prove to the FDA that their products are effective and safe before they sell them to the public. Regulators do monitor aftermarket reports for indications of potential problems and recently, companies have been under pressure and tightened requirements to alert the FDA when this occurs.
Katz lamented it’s taken so long to ‘get a handle’ on the Hydroxycut problem because the cases of liver damage were rare and the FDA has no authority to review supplements before they are marketed. “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. Also, the agency relies on voluntary information to detect a red flag situation. Many times, cases are never reported.
Based on available information, health officials said they cannot determine which Hydroxycut ingredients or proprietary blends are the toxic culprits, perhaps because the product formulation has changed several times. But last month a medical journal report speculated that one ingredient…a tropical fruit derivative, hydroxycitric acid, could possibly cause liver damage.
Also, the Food and Drug Administration said it could not ascertain which other factors, such as length of use, dosage, combining with other supplements or drugs, or one’s health condition could affect the risk of using Hydroxycut.