FDA Links Dietary Supplement Kava to ‘Potential Risk’ of Severe Liver Damage
The FDA warned yesterday that kava, a dietary supplement used to treat sleeplessness, stress, anxiety and menopausal symptoms, has a "potential risk" of causing severe liver damage, the Los Angeles Times reports (Garvey, Los Angeles Times, 3/26). The agency last month launched an investigation into kava after 38 Americans experienced medical problems possibly related to kava use, including a 45-year-old woman who suddenly required a liver transplant. In addition, European health officials have reported 25 cases of kava-related liver toxicity, including four liver transplants. Sales of the supplement have been stopped in Switzerland and France and suspended in Britain. Germany has moved to make kava a prescription drug and Canada is urging consumers not to take it until the safety questions can be resolved (AP/Las Vegas Sun, 3/26). The FDA is searching for a "biological relationship" between kava and liver damage, the Times reports, and has advised kava users to watch for symptoms of liver damage, such as jaundice and brown urine. Kava -- also known as ava, awa, intoxicating pepper and kew -- is the ninth-most-popular herbal supplement in the United States. The FDA's warning is the latest in a "string of enforcement efforts" targeted at regulating the supplement industry, the Times reports. FDA spokesperson Ruth Welch said, "We're saying there is some reason for concern, but we do not have a biological explanation for this" (Los Angeles Times, 3/26).
In related news, the Wall Street Journal today reports that the recent withdrawal from the market of PC-Spes, an herbal supplement used to treat prostate cancer, is a "vivid illustration of gaps in the regulation of herbal products" (Burton, Wall Street Journal, 3/26). BotanicLab Inc., a California-based supplement manufacturer, last month voluntarily recalled PC-Spes after the Department of Health Services found that the treatment contained the blood-thinning prescription drug Coumadin (California Healthline, 2/11). Barre Rorabaugh, BotanicLab's CEO, said his company does not "have complete control of the supply chain" for PC-Spes, and he is unsure how the supplement became contaminated (Wall Street Journal, 3/26).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.