Correspondence

Problems Evaluating Contamination of Dietary Supplements

N Engl J Med 1999; 340:568February 18, 1999

Article

To the Editor:

The investigation by Slifman and colleagues of the contamination of a dietary supplement with Digitalis lanata (Sept. 17 issue)1 is a splendid example of how cause and effect can be established by clinical correlation and the use of laboratory analysis of both the patient's serum and the ingested product. Unfortunately, an adequate workup of such cases is the exception. Although digoxin assays are generally available, assays of body fluids for other botanicals and dietary supplements are not. . . .

The unavailability of tissue assays for dietary supplements hampered our study group's effort to evaluate causation in many cases of ingestion reported to 12 poison-control centers in 1998.2 In 36 percent of 1025 cases, symptoms associated with ingestion were reported, and 217 of these cases met our clinical criteria for at least a 50 percent probability that ingestion caused the symptoms, including two cases involving fatal myocardial infarction, seven involving seizures, five involving hepatotoxicity, and three involving coagulopathy. Of particular concern are “thermogenic” products such as ephedra, yohimbine, and caffeine-containing botanicals. The unavailability of assays for laboratory analysis compounds the problem of the dearth of pre- and post-marketing data on toxicity.

Mary E. Palmer, M.D.
ToxEM, Alexandria, VA 22314

Rama B. Rao, M.D.
New York City Poison Control Center, New York, NY 10016

2 References

1. 1

   Slifman NR, Obermeyer WR, Aloi BK, et al. Contamination of botanical dietary supplements by Digitalis lanata. N Engl J Med 1998;339:806-811
   Full Text | Web of Science | Medline

2. 2

   Palmer M, Haller C, McKinney P, et al. A gap in the safety net: a multi-center prospective study of herbals and other dietary supplements. J Toxicol Clin Toxicol 1998;36:454-454 abstract.
   

Citing Articles (2)

Citing Articles

1. 1

   Scott A. Jordan, David G. Cunningham, Robin J. Marles. (2010) Assessment of herbal medicinal products: Challenges, and opportunities to increase the knowledge base for safety assessment. Toxicology and Applied Pharmacology 243:2, 198-216
   CrossRef

2. 2

   Mary E Palmer, Christine Haller, Patrick E McKinney, Wendy Klein-Schwartz, Anne Tschirgi, Susan C Smolinske, Alan Woolf, Bruce M Sprague, Richard Ko, Gary Everson, Lewis S Nelson, Teresa Dodd-Butera, W Dana Bartlett, Brian R Landzberg. (2003) Adverse events associated with dietary supplements: an observational study. The Lancet 361:9352, 101-106
   CrossRef