Bo Ying Compound by Eu Yan Sang (Hong Kong) Ltd: FDA/CDER Statement – Risk of Lead Poisoning

This is a reprint of an FDA Alert.

AUDIENCE: Consumer, Health Professional, Pediatrics, Family Practice

ISSUE: FDA warns parents and caregivers not to use “Bo Ying compound” manufactured by Eu Yan Sang (Hong Kong) Ltd. due to the potential lead poisoning risk associated with the product.

FDA learned of this risk from the New York City Department of Health & Mental Hygiene after the product was tested and found to contain high levels of lead. FDA has received one adverse event report of lead poisoning in an 18-month-old child who was given this product. See the FDA/CDER Statement for product photos.

Exposure to lead can cause serious damage to the central nervous system, the kidneys, and the immune system. In children, chronic exposure to lead, even at low levels, is associated with impaired cognitive function, including reduced IQ, behavioral difficulties, and other problems.

BACKGROUND: The powdered product is marketed in retail outlets and online for use in infants and children for treatment of a variety of conditions including influenza, fever, sneezing, and nasal discharge. The product is labeled in Chinese and English.

RECOMMENDATION: Parents and caregivers are advised to not purchase or use this product. Anyone using this product or providing it to a child should immediately consult a health care professional.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm

• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178