with AP reports A warning that the popular herbal supplement kava may be linked to serious liver injury generated mixed responses on Kaua’i. The Food and Drug Administration issued the warning Monday, urging consumers to see a doctor at the
with AP reports
A warning that the popular herbal supplement kava may be linked to serious liver injury generated mixed responses on Kaua’i.
The Food and Drug Administration issued the warning Monday, urging consumers to see a doctor at the first sign of symptoms.
People who already have liver problems, or who take medications that can harm the liver, should ask a doctor before taking kava, the FDA said.
The warning has had a mixed impact on some Kaua’i pharmacies and natural food stores.
Some merchants have stopped selling kava products, while other merchants say they will warn customers about potential adverse effects of kava, but will continue to sell the products until they are recalled by the federal government.
Patti Valentine, manager of the supplement section at Papaya’s Natural Food & Cafe, the largest natural food store on Kaua’i, said the sale of kava products remains “status quo.”
Valentine blamed pharmaceutical companies that manufacture kava products for the problem.
“Manufacturers sometimes use a chemical solvent, which is possibly toxic, to extract one constituent (a part of the kava plant) which has been shown to have the most potent effective change,” she said. “You just don’t go out and pull out constituents left and right.”
Valentine said the entire kava plant, as a calming agent, works just as effectively as parts of the plant that are extracted by manufacturers of kava products. “It is a pharmaceutical concept, not a herbalist concept,” she said.
Valentine said her store doesn’t sell kava products that are connected with the process used by manufacturers of kava.
Kava products are generally sold in the form of powder or chopped pieces of kava plant.
Vicki Yarberry, owner of Hanalei Health and Aloha Juice Bar at the Ching Young Village, said she is aware of the warnings about kava products, but will continue to sell them until they are “recalled” by the FDA.
“It is good for us as long as it is a good item,” she said.
To date, scientists have not confirmed that a mainland woman suffered liver damage from the use of kava products, and until they do, her store will sell the herb, Yarberry said.
Yarberry said kava products produce many beneficial health effects, including relaxing frayed nerves and soothing sore throats. Kava cultivation also is a budding industry on Kaua’i for local farmers, she added.
But Bill Farlander, a pharmacist and owner of Westside Pharmacy in Hanapepe, the oldest pharmacy on the island, said he pulled kava products off the shelf a month ago after reading medical journals discussing the potential ill effects from the use of the herb.
“If I hear bad things about it, why would I sell it?” Farlander said.
The FDA began investigating the blockbuster-selling herb after a previously healthy 45-year-old woman used kava and suddenly required a liver transplant. European health officials report 25 similar cases of liver toxicity, including four transplants.
As a result, Canada has urged consumers not to take kava until the safety question is settled; sales were halted in Switzerland and France and suspended in Britain; and Germany is acting to make kava a prescription drug.
The FDA hasn’t concluded if kava, or its use together with some other supplement or medication, is truly to blame. But the seriousness of side effects, and other countries’ actions, made FDA officials decide it was time to alert Americans even as they struggle to solve the mystery.
“This kind of liver damage appears to be extremely rare. But because it’s severe liver damage, we felt consumers needed to be aware of it,” said FDA supplement chief Dr. Christine Taylor.
Kava users should consult a doctor if they experience any possible symptoms of liver disease, the FDA said.
Those include: Jaundice, or yellowing of the skin or eyes; brown urine; nausea or vomiting; light-colored stools; unusual tiredness or weakness; stomach or abdominal pain, or loss of appetite.
The FDA said kava is sold under a variety of names, including: ava, awa, intoxicating pepper, kava root or pepper, kawa, kew, Piper methysticum, rauschpfeffer, sakau, tonga, wurzelstock and yangona.
In a letter to physicians, the FDA said it will soon provide them as much scientific information as is available to help in advising patients wondering whether to take kava.
The FDA also urged doctors and consumers to report any possible kava side effects by calling 1-800-332-1088 or via the Internet at http://www.fda.gov/medwatch.
Under federal law, no one has to prove dietary supplements are safe or work as advertised before they begin selling.
And, unlike in other countries, the FDA must prove one is dangerous before it can halt sales. Reports of kava users suffering liver injury suggest a link, but it will take more research to prove if the herbal sedative actually causes injury, Taylor said.
She wouldn’t say how many ill American kava users are being investigated because the number changes slightly each week as FDA reviews more medical records. But as of last month, the agency was examining about 38.
By making it clear that the jury’s still out, FDA’s consumer alert was “a prudent and an appropriate precautionary move,” said John Cordero of the industry’s Council for Responsible Nutrition.
The consumer advocacy group Center for Science in the Public Interest had pushed FDA to issue the warning for months. “We urge consumers to steer clear of kava altogether unless directed otherwise by a physician,” said CSPI’s Bruce Silverglade.
Kava is promoted to relieve anxiety, stress and insomnia. A member of the pepper family, it has long been used as a ceremonial drink in the South Pacific; until recently its biggest danger seemed to be in drinking too much of the sedative before driving. Then, about two years ago, kava in pill form suddenly boomed, bringing in about $30 million in sales – and Europe reported liver damage.
Herb experts say it’s possible that if kava is dangerous, it might be only to certain people. That’s because some of the European patients already had some liver damage before using kava or used alcohol or other known liver-harming substances in addition to the herb.
The controversy is the latest bad news for the $16 billion supplement industry, which reported sharp sales declines last year. Since last summer, the FDA has issued repeated warnings about supplements tainted with drugs and chemicals illegally posing as supplements, and asked makers of the liver-damaging herb comfrey to stop selling it for internal use.
On the Net:
FDA: http://www.cfsan.fda.gov/ 7/8dms/addskava.html
