FDA recall: What were the reasons with Hydroxycut?

The Food & Drug Administration issued on May 1 a consumer warning to stop using Hydroxycut, the heavily marketed weight-loss product. The agency said that “some Hydroxycut products are associated with a number of serious liver injuries” and announced that the maker was recalling all products.

Did the FDA properly react? The warning cited 23 serious health problems, including jaundice, liver damage, seizures and cardiovascular disorders. One person has died from liver failure since 2002 when the Center for Food Safety and Applied Nutrition first received reports about liver damage associated with intake of Hydroxycut.

Some people — for reasons not totally understood — had adverse reactions to Hydroxycut, according to a research report cited in the FDA warning. Sometimes the individuals required serious treatment for liver damage. Other times, the people regained normal health when they stopped taking the product.

Until 2004, Hydroxycut contained ephedra, a substance that the FDA banned after a study found more than 16,000 adverse events associated with its use in dietary supplements. According to a recent label, the main ingredients in Hydroxycut are now the minerals calcium, chromium and potassium, plus what the company calls Hydroxagen Plus and HydroxyTea. The former contains leaf and rind extracts and the latter is a combination of tea and ginger extracts.

None are banned substances. And the  health hazard evaluation board acknowledged in its report that it “does not know what ingredient(s) of Hydroxycut are responsible for producing liver toxicity. In addition, there is insufficient information to determine whether there is a dose-response effect between Hydroxycut ingestion and liver disease or whether its effects are cumulative over time.”

The board concluded, “Three lines of evidence derived from multiple disparate sources suggest it is very likely that exposure to Hydroxycut can cause idiosyncratic hepatotoxicity.”

Some definitions are in order. According to a 2007 article in Toxicological Sciences, “Idiosyncratic hepatotoxicity is a rare and unpredictable event of liver injury affecting generally less than 1 in 10,000 patients treated with certain drugs. However, it is a serious clinical problem as it accounts for 10% of all drug-induced liver failure cases.”

And citing a study published in May 2005 in the Nature Reviews Drug Discovery, the article said, “Idiosyncratic hepatotoxicities are currently the main cause for Food and Drug Administration-mandated warnings, restrictions of use or even withdrawals of drugs from the market.”

So, the FDA puts great weight on idiosyncratic hepatoxicity even though it is uncommon and difficult to predict in a population. Given the level of uncertainty, did the FDA have other options? After conducting a risk-benefit analysis, could the agency have told the makers of Hydroxycut to add a warning to immediately discontinue use and seek medical attention if certain symptoms present themselves? Why did an average of three cases per year — none this year and only three last year — justify a ban and recall?

Here’s a clue from the report, which references the Center for Food Safety and Applied Nutrition as CFSAN:  “In discussions in March and April of 2009 with hepatologists Tse-Ling Fong, M.D. of the University of Southern California and William Lee, M.D. of the University of Texas Southwestern Medical Center, CFSAN has become aware of these physicians’ case series of patients with severe liver disease associated with the use of Hydroxycut. Two cases from this series, representing additional cases to the ones reported to CFSAN, underwent liver transplantation following acute liver failure.”

Were the doctors two of the three sources? And were their case series the underlying reason for such swift and final FDA action? The answers are not here, but they are needed.

About 

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

Joel B. Rothman represents clients in intellectual property infringement litigation involving patents, trademarks, copyrights, trade secrets, defamation, trade libel, unfair competition, unfair and deceptive trade practices, and commercial matters. Joel’s litigation practice also includes significant focus on electronic discovery issues such as e-discovery management and motion practice relating to e-discovery.

Related posts

Top