“Consumers should seek medical advice if they develop any symptoms suggestive of liver disease such as jaundice (yellowing of the skin) and are encouraged to report such events to the TGA,” said a TGA spokesperson.
The TGA review follows the hospitalization of a man for eight days with severe acute hepatitis. He said he had consumed Hydroxycut Hardcore for 10 weeks at recommended levels and has since made a full recovery.
The Food and Drug Administration (FDA) warned consumers off a range of Hydroxycut products in May, 2009, after a number of adverse events including a death were discovered.
Hydroxycut owner, Iovate Health Sciences, voluntarily withdrew the whole range, reformulated with only caffeine remaining from the original products and reintroduced it with slightly different branding soon after.
A spokesperson was unavailable for comment by the time of publication.
Same, but different
In Australia, a locally manufactured version can be purchased in health stores and the US version is apparently available via the internet. The TGA said the Australian version had a different formula to its relaunched US counterpart.
Doctors who treated the Sydneysider for severe acute hepatitis said consumers should be wary of the product that contains that contains caffeine, vitamin C and herbal extracts.
The man said he had not exceeded recommended dosages and had consumed the supplement for 10 weeks before the symptoms kicked in. He was hospitalized for eight days but made a full recovery.
Privately-owned Iovate distributes hundreds of weight loss and muscle-building products and is present in more than 60 countries.
The FDA-prompted voluntary recall in May came after Iovate reported an Hydroxycut-related death, on top of 23 adverese reports the FDA had received over seven years.
FDA investigations then revealed that Iovate had more than 2000 unreported adverse events on its books it deemed of mild seriousness and hence had not reported them.
The subsequent recall confounded some in that the actual ingredient or ingredients causing the problem were never isolated or revealed.
An FDA spokesperson told NutraIngredients-USA.com: “The only ingredient left in from the original formulation is caffeine. We do not have any evidence that caffeine causes liver toxicity,”
Iovate was to review the ingredients but there has been no publication of these findings, although the company said in a web posting that third-party experts, “review the safety of Iovate’s ingredients and formulas before products are introduced in the marketplace.”
The company is also facing several lawsuits mounted by some of those claiming liver, muscle and other problems from using the products.
The FDA advisory at the time stated that: “Although the liver damage appears to be relatively rare, FDA believes consumers should not be exposed to unnecessary risk.”
The likes of GNC and Vitamin Shoppe are carrying the products now.
To read a letter recording FDA’s first meeting with Iovate on March 31 click here .
Ingredients currently used in weight loss supplements include: bitter orange, chromium, guar gum, hoodia, garcinia, Conjugated Linolenic Acid (CLA), pyruvate and chitosan.