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Choose article section... Warning: Kava kava may cause liver damage Commission E vs. the FDA Another approach to awakening at night Too much to touch on, so little time

Warning: Kava kava may cause liver damage

I read with delight the article by Drs. Gardiner and Kemper ("Insomnia: Herbal and dietary alternatives to counting sheep," February). I applaud Dr. Kemper, who is probably the world's leading authority on integrating allopathic and complementary and alternative pediatric medical care.

Among the herbs the article lists for alleviating insomnia is kava kava. The authors mention a few problems associated with this herb, but it is important to point out that more than 30 cases of severe liver damage associated with the use of kava kava have now been reported in Germany and Switzerland, including one death and four cases of liver failure (Esher et al: BMJ 2001;322:139; Kraft et al: Dtsch Med Wochenschr 2001; Sept 7:126; Russman et al: Ann Intern Med 2001;135:68). As a direct result of these adverse reactions, authorities in Germany, Switzerland, France, and the United Kingdom have either banned or are considering banning kava kava. Canadian health officials are examining whether to consider similar action. The US Food and Drug Administration, aware of the problem, asked for additional information in a letter sent to health-care professionals on December 18, 2001. This FDA action was prompted by 58 reports of adverse reactions, including one case of liver disease that necessitated liver transplant.

In addition to liver problems, kava kava has long been associated with "kawaism" in some patients. This skin condition is characterized by dry, flaking, jaundiced skin and infected conjunctiva. Recently, kava kava has been reported to cause life-threatening parkinsonism. The American Herbal Products Association, a prominent herb industry trade group, recommended in 1997 that herbs containing kava kava be labeled "not to be used by people under 18 or by pregnant or nursing women without professional advice." Kava kava is also suspected of causing skeletal muscle relaxation that impairs motor control, in turn causing problems with driving a motor vehicle. In view of the serious toxicities associated with kava kava, I believe it should be excluded from use in pediatrics.

Gerald Ente, MD
Westbury, N.Y.

The authors reply: Since we prepared our article, there have been a growing number of reports linking kava kava (Piper methysticum) to hepatic damage. As Dr. Ente notes, the FDA is now warning of a possible link between kava kava and liver toxicity and is investigating the situation. Kava kava is widely used in the United States, not only to treat insomnia but for premenstrual syndrome and anxiety. Safety concerns arose when Germany and Switzerland reported approximately 30 cases of liver toxicity in patients using kava kava. The recent FDA letter to health-care professionals asks them to review their cases of liver toxicity to discern any link to dietary supplements containing kava kava. Adverse events can be reported to the FDA at 800-332-1088 or .

Paula Gardiner, MD
Kathi J. Kemper, MD, MPH

Commission E vs. the FDA

I strongly object to Dr. Gardiner's and Dr. Kemper's characterization of the German Commission E as the equivalent of the FDA ("Insomnia: Herbal and dietary alternatives to counting sheep," February). The commission requires no controlled studies of efficacy or safety. The publications on herbal products are essentially a compendium of claims that have been presented to the commission without scientific evidence. This is not the equivalent of our evidence-based drug testing system. Equating rumor-based consonance with evidence misrepresents the claims of efficacy made for these products.

Joseph J. Keeley, MD
Orlando, Fla.

The authors reply: The German Commission E is, like the FDA, a federally sponsored organization, and they are similar in their focus on consumer safety and product efficacy. However, the German Commission E evaluates herbs and the FDA reviews pharmaceuticals. In 1978, the German government appointed a committee comprising physicians, pharmacologists, toxicologists, and others to evaluate the safety and efficacy of herbal medicines by reviewing the scientific literature. The Commission E evaluated data obtained from clinical trials, field studies, and collections of single cases, and information from standard herbal reference works. Although the FDA rigorously evaluates pharmaceuticals, it does not review herbal efficacy in the same way because the 1994 Dietary Supplement Health and Education Act classifies herbs as dietary supplements.

Paula Gardiner, MD
Kathi J. Kemper, MD, MPH

Another approach to awakening at night

Dr. Kemper's advice for dealing with a young toddler who wakes up at night for a feeding ("Behavior: Ask the Experts," January) is both sage and appropriate. At times, however, it is helpful to think outside of the box. In the case of an infant or young child awakening at night and demanding parental intervention, the key often lies in his (or her) initial bedtime routine. Almost invariably the child is rocked to sleep, fed to sleep, cuddled to sleep, or otherwise has the parent play some integral, physical part in his settling/falling asleep transition. When the child has a "normal" awakening at night (that is, not one caused by an unusual disturbance), he fusses as a way to get the parent to initiate the rocking/feeding/cuddling/etc. that is part of that settling/falling asleep transition.

These children act as if they are unaware they have been asleep: One moment the treasured parent is holding or feeding them, the next instant the parent has vanished—a very disquieting experience, to say the least. The problem classically presents around 9 months of age (at which time the partial acquisition of object constancy exacerbates the problem). The principles hold true as well for the 16-month-old toddler described in the vignette.

The key, then, is to use the progressive approach described at the initial bedtime transition first. When an independent "settling/ falling asleep" has been established, the middle of the night awakening (if not already magically "cured") is much easier to extinguish.

Christopher Goff, MD
Old Saybrook, Conn.

Too much to touch on, so little time

Finally! After years of reading from ivory-tower based colleagues who have never done a day of private practice in their careers and who suggest all the things we need to incorporate into the 14.2 minutes that constitute an office visit, it was soothing to read Dr. Gephart's commentary (How much time [and evidence] for promoting health? February, p. 108). Dr. Gephart raises the voice of reason that we primary care physicians have been sounding for years: How are we to incorporate all of the recommendations for counseling into our limited time? Bring the patient back? In a world of capitated payments, that's not realistic. I agree with Dr. Gephart that specific, age-appropriate topics based on evidence and that reflect those areas that constitute the greatest risk to the child could be covered at a well-child visit. But the panoply of subjects now recommended—not likely!

Alan Levine, MD
Levittown, N.Y.


Readers' Forum. Contemporary Pediatrics 2002;5:153.

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