05.01.02
FDA recently issued an advisory for kava and its association with severe liver toxicity. FDA’s letter to healthcare professionals states, “In this advisory, we discuss that although rare, hepatic failure has been reported to be associated with the use of kava-containing products. Additionally, we advise consumers of the early signs of liver toxicity and recommend that persons who have liver disease or liver problems, or persons who are taking drug products that can affect the liver, should consult a physician before using kava-containing supplements.” In response to this the American Herbal Products Association (AHPA), Silver Spring, MD, has revised its recommendation for kava, originally established in 1997. AHPA now recommends the following dosage and labeling policies for food and dietary supplement products containing kava (Piper methysticum): Products containing kava should be formulated and labeled to limit consumption of total kavalactones to 300 mg per day and labels of food and dietary supplement products containing kava should bear the following or significantly similar statement:
Caution: Ask a healthcare professional before use if you have or have had liver problems, frequently use alcoholic beverages, or are taking any medication. Stop use and see a doctor if you develop symptoms that may signal liver problems (e.g., unexplained fatigue, abdominal pain, loss of appetite, fever, vomiting, dark urine, pale stools, yellow eyes or skin). Not for use by persons under 18 years of age, or by pregnant or breastfeeding women. Not for use with alcoholic beverages. Excessive use, or use with products that cause drowsiness, may impair your ability to operate a vehicle or heavy equipment.
Caution: Ask a healthcare professional before use if you have or have had liver problems, frequently use alcoholic beverages, or are taking any medication. Stop use and see a doctor if you develop symptoms that may signal liver problems (e.g., unexplained fatigue, abdominal pain, loss of appetite, fever, vomiting, dark urine, pale stools, yellow eyes or skin). Not for use by persons under 18 years of age, or by pregnant or breastfeeding women. Not for use with alcoholic beverages. Excessive use, or use with products that cause drowsiness, may impair your ability to operate a vehicle or heavy equipment.