Adult Lead Poisoning from an Asian Remedy for Menstrual Cramps -- Connecticut, 1997

Follow-back procedures to determine the source of elevated blood lead levels (BLLs) are integral parts of the CDC's National Institute for Occupational Safety and Health Adult Blood Lead Epidemiology and Surveillance program (ABLES) in 27 states. Although an estimated 90%-95% of cases of elevated BLLs reported to the states in the ABLES program result from occupational exposures, nonoccupational exposures also are identified by this system. This report describes a case of adult lead poisoning attributed to an Asian remedy for menstrual cramps, "Koo Sar" pills, following an investigation by the Adult Lead Registry of the Connecticut Department of Public Health (CDPH), Division of Environmental Epidemiology and Occupational Health.

On February 19, 1997, a 33-year-old Cambodian woman, her husband, and their two children were screened at a free lead-screening event sponsored by a nursing school community health promotion center. The husband had a BLL of less than 10 ug/dL, and the children, aged 8 and 2 years, had BLLs of 2 ug/dL and 3 ug/dL, respectively. The woman, however, had a BLL of 44 ug/dL and a confirmatory BLL on March 3 of 42 ug/dL. * The woman reported no symptoms associated with lead poisoning (e.g., muscle pains or weakness, headaches, or loss of appetite).

On March 14, 1997, the director of the health promotion center notified the CDPH's case-management coordinator for the Adult Lead Registry; the coordinator interviewed the woman by telephone for follow-up. The CDPH coordinator requested samples of any medicines, teas, or cosmetics that the woman had used that might have been the source of the lead. All submitted materials (teas, medicinal herbs, cosmetics, and two of three bottles of red pills in their original containers) were sent to the CDPH State Laboratory for analysis. Lead was found only in the red pills, at concentrations of 3.5 ppm in pills from bottle A and 1.2 ppm in pills from bottle B. **

On April 1, 1997, a CDPH follow-up interview revealed that for 3-4 years the woman had taken six of these pills per day on 7 days of each month to treat menstrual cramps. She was advised to stop taking the pills and was asked to submit additional pills for further investigation. After she stopped using the pills, follow-up BLLs were 28 ug/dL in April, 21 ug/dL in May, 19 ug/dL in June, and 12 ug/dL in September 1997.

Because the woman originally had reported purchasing the pills in New York City, samples were sent to the New York City Department of Health for confirmation and follow-up. On October 10, 1997, laboratory results from New York showed lead in amounts of 12.5 ppm in pills from bottle A and 4.5 ppm in pills from bottle B. Additional follow-up with the woman indicated that both bottles actually had been obtained in San Francisco, California.

CDPH contacted the California Department of Health Services, and the matter was referred to the San Francisco Department of Public Health for investigation, including review of the package literature (written in Chinese) that accompanied the pills. The product or brand name listed on the outside of the package was "Koo So Pills," and on the package insert it was "Koo Sar Pills." The manufacturer, Tien Sau Tong, is in Hong Kong. Lead is not among the 11 listed ingredients. The insert states, "These medical pills are good for general debility." The directions for dosage are one pill taken with warm water two times daily. The lead content of pills from two packages of Koo Sar pills purchased at different shops in San Francisco was 2.7 ppm lead (0.9 ug/pill) and 4.3 ppm (1.5 ug/pill), respectively.

No additional cases of lead poisoning associated with Koo Sar pills have been reported to California, Connecticut, New York, or to any of the other state ABLES programs. Food and drug authorities at the state (California) and federal level were notified of this incident; no recall or other regulatory action has been initiated.

Reported by: BC Jung, MPH, Connecticut Dept of Public Health, Div of Environmental Epidemiology and Occupational Health; M Morrissey-Ross, MSN, Fairfield Univ School of Nursing Health Promotion Center, Fairfield, Connecticut. L Nicaj, New York City Dept of Health. D Lo, San Francisco Dept of Public Health; B Materna, PhD, R Fornes, MS, California Dept of Health Services. Div of Surveillance, Hazard Evaluations, and Field Studies, National Institute for Occupational Safety and Health, CDC.

Editorial Note

Editorial Note: This report describes a previously unrecognized source of lead poisoning from a traditional or folk remedy. This is the only known case resulting from Koo Sar pills, but other cases may have occurred; elevated BLLs in persons who are asymptomatic may not be diagnosed (this case was identified serendipitously), and diagnosed cases may not have been reported. Because lead is not listed as an ingredient of Koo Sar pills, it is thought to be a constituent or contaminant of the red dye used to color the pills. The varying lead concentrations measured in different samples of the pills probably result from varying amounts of lead present during manufacture of the red dye.

Adulterants, including lead, have been noted in Asian traditional or folk medicines (2,3). Folk remedies and cosmetics from East Indian, Pakistani, Chinese, and Latin American cultures that have contained lead include alarcon, alkohl, azarcon, bali goli, coral, gliasard, greta, kohl, liga, pay-loo-ah, rueda, and surma (4). Other sources of lead ingestion have included contaminated ground paprika (5), ayurvedic metal-mineral tonics (6), Deshi Dewa (a fertility drug) (7), hai gen fen (clamshell powder) added to tea (8), and pigment used in plastic wire insulation (9).

Traditional or folk remedies taken by persons for various ailments should be considered by health-care providers as possible sources of adult lead poisoning -- particularly when an occupational exposure cannot be identified. Educational interventions should be targeted toward ethnic communities known to use such folk remedies by state and municipal health departments and other community groups; educational materials should warn of the dangers of using folk remedies that might contain toxic ingredients that can lead to adverse health effects.

References

1. CDC. Update: blood lead levels -- United States, 1991-1994. MMWR 1997;46:141-6.

2. Ko, RJ. Adulterants in Asian patent medicine {Letter}. N Engl J Med 1998;339:847.

3. Beigel Y, Ostfeld I, Schoenfeld N. Clinical problem solving: a leading question. N Engl J Med 1998;339:827-30.

4. Mulroy MT, Filchak K, Gaudio M. What you should know about lead poisoning: a resource manual for childcare providers. Hartford, Connecticut: Connecticut Department of Public Health, 1997:I-10.

5. Kakosy T, Hudak A, Naray M. Lead intoxication epidemic caused by ingestion of contaminated ground paprika. J Toxicol Clin Toxicol 1996;34:507-11.

6. Prpic-Majic D, Pizent A, Jurasovic J, Pongracic J, Restek-Samarzija N. Lead poisoning associated with the use of Ayurvedic metal-mineral tonics. J Toxicol Clin Toxicol 1996;34:417-23.

7. Kulshrestha MK. Lead poisoning diagnosed by abdominal x-rays. J Toxicol Clin Toxicol 1996;34:107-8.

8. Hill GJ, Hill S. Lead poisoning due to hai gen fen. JAMA 1995;273:24-5.

9. Carey B. The case of the addled electrician. Health 1994;8:122.

CDPH regards adult BLLs less than 10 ug/dL as normal; the geometric mean blood lead level for adults aged 20-49 years in the Third National Health and Nutrition Examination Survey (1991-94) was 2.1 ug/dL (1). ** Laboratory analysis was performed using acid digestion and graphite flame absorption (EPA method 200.9).

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