In the News
In the News
Recall of PC SPES
Consumers should immediately stop using the dietary supplement herbal products PC SPES and SPES because they contain undeclared prescription drug ingredients that could cause serious health effects if not taken under medical supervision. PC SPES and SPES are marketed for prostate health and strengthening the immune system, respectively.
BotanicLab, the Brea, CA-based manufacturer, has voluntarily recalled PC SPES and SPES nationwide.
The California Department of Health Services’ (CDHS) Food and Drug Branch conducted a laboratory analysis of the products and found PC SPES contains warfarin and SPES contains alprazolam. PC SPES is available in 60-capsule bottles, and SPES is available in 30-capsule bottles, through mail or telephone order, Internet sales, distributors, retailers, and health care professionals.
Consumers who have unused SPES and PC SPECS capsules should return the product in its original packaging to PC SPES Recall Program, 2900-B Saturn St., Brea, CA 92821, or call (800) 458-5854. CDHS’ Food and Drug Branch is continuing to investigate these products and can be reached at (800) 495-3232 for more information. The U.S. Food and Drug Administration is assisting in the investigation and monitoring of the recalls throughout the United States.
To view the recall notice, visit: http://www.botanic-lab.com/html/recall.html.
Kava Linked to Liver Toxicity
The Food and Drug Administration (FDA) is investigating whether the use of dietary supplements containing kava (also known as kava kava or Piper methysticum) is associated with liver toxicity. To help determine whether there is a problem in the United States, the FDA is asking that physicians review cases of liver toxicity to determine if any may be related to the use of kava-containing dietary supplements.
Products containing herbal extracts of kava have been implicated in cases of serious liver toxicity in Germany and Switzerland. Approximately 25 reports of hepatic toxicity associated with the use of products containing kava extracts have been reported in these countries. Serious hepatic adverse effects include hepatitis, cirrhosis, and liver failure. At least one patient required a liver transplant. Based on their assessment of the adverse events reported to them, the regulatory authority in Switzerland has prohibited the sale of products containing the kava extract associated with the adverse effects. Last month, the German authorities issued a proposal to remove all kava extract-containing products from the market.
FDA is investigating whether the use of kava-containing dietary supplements in the United States poses similar public health concerns. The agency has received several reports of serious injury allegedly associated with the use of kava-containing dietary supplements, with at least one report of hepatic failure requiring liver transplantation in a previously healthy young female.
Dietary supplements containing kava are promoted for a variety of uses, including relaxation (e.g., to relieve stress, anxiety, and tension), insomnia, and premenstrual syndrome.
Because of the potentially serious nature of these concerns, any cases of hepatic toxicity or other adverse events that may be related to the use of kava-containing dietary supplements should be reported as soon as possible to FDA’s MedWatch program by telephone: (800) 332-1088 or through the Internet: http://www.fda.gov/medwatch.
Lipokinetix and Liver Injury
Lipokinetix, distributed by Syntrax Innovations Inc., has been implicated in several cases of serious liver injury. The Food and Drug Administration (FDA) has received reports of at least six persons who developed acute hepatitis and/or liver failure while using Lipokinetix. The injuries reported to FDA occurred in persons between 20 and 32 years of age. No other cause for liver disease was identified. In all cases, no pre-existing medical condition that would predispose the consumer to liver injury was identified. Onset of liver injury was observed between two weeks and three months of starting Lipokinetix.
Lipokinetix has been promoted for weight loss by mimicking exercise and supporting an increased metabolic rate. The product contains norephedrine (also known as phenylpropanolamine or PPA), caffeine, yohimbine, diiodothyronine, and sodium usniate.
FDA has issued a consumer warning advising consumers to stop using this product and to consult their physician if they are experiencing symptoms possibly associated with this product, particularly nausea, weakness or fatigue, fever, abdominal pain, or any change in skin color.
FDA urges physicians to review all cases of hepatitis in order to determine if any may be related to the use of dietary supplements in these patients. Adverse events associated with the use of dietary supplements should be reported as soon as possible to FDA’s MedWatch program by telephone: (800) 332-1088 or via the Internet: http://www.fda.gov/medwatch.
Distinguished Lecture Series on CAM
The National Center for Complementary and Alternative Medicine (NCCAM), a component of the National Institutes of Health (NIH), recently announced the launch of the Distinguished Lecture Series on Complementary and Alternative Medicine (CAM).
A national survey revealed that in 1997 more than 42% of the American public used CAM, at a cost of $27 billion per year, which exceeded out-of-pocket spending for all U.S. hospitalizations. In 1998, the Congress established the NCCAM to stimulate, develop, and support research in CAM for the benefit of the public. The NCCAM is an advocate for high-quality science, rigorous, and relevant research, and open and objective inquiry into which CAM practices work, which ones do not, and why. Its overriding mission is to give the American public reliable information about the safety and effectiveness of CAM practices.
The new CAM lecture series offers an opportunity for NIH staff, scientists, and the public to come together to learn about current thinking and research, and engage in constructive dialogue about innovative approaches to integrated disease prevention and management.
The first lecture was given by Stephen E. Straus, MD, director of NCCAM, on March 11. Future lectures will include talks on July 25, by Charles Rosenberg, PhD, professor of the History of Science, and Ernest E. Monrad, Professor in the Social Sciences, Harvard University. On Nov. 7, Arthur Kleinman, MD, professor of Social Anthropology, Harvard University, and Lillian Presley, Professor of Medical Anthropology and Psychiatry, Harvard Medical School, will present a talk.
For more information about this lecture series, visit http://nccam.nih.gov or contact Linda Gaskill by telephone: (301) 984-7191 or email: [email protected].
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