FDA MedWatch - Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead

MedWatch - The FDA Safety Information and Adverse Event Reporting Program

Balguti Kesaria Ayurvedic Medicine: FDA Warning - High Levels Of Lead

AUDIENCE: Consumers, Health Care Professionals
ISSUE: The U.S. Food and Drug Administration is warning parents and caregivers not to use “Balguti Kesaria (or Kesaria Balguti) Ayurvedic Medicine” due to the risk of lead poisoning.
FDA has not reviewed this product for safety or effectiveness. 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: This product is sold online and manufactured by multiple companies, including Kesari Ayurvedic Pharmacy in India. Individuals have also mailed or brought the product into the United States. “Balguti Kesaria Ayurvedic Medicine” is used with infants and children for a variety of conditions including rickets, cough and cold, worms and dentition (teething).
FDA initially learned of this risk from the North Carolina Division of Public Health after the product was tested and found to contain high levels of lead. FDA was also notified by the Michigan Department of Health and Human Services of high levels of lead in two children who were given this product. Michigan’s testing also found high levels of lead in the product. To date, FDA has received one adverse event report of high levels of lead and developmental delays in a child who was given this product.
RECOMMENDATION: Anyone who is using this product or giving it to a child should stop immediately and consult a health care professional.
Health care professionals and consumers are encouraged to report any adverse events potentially related to “Balguti Kesaria Ayurvedic Medicine”or any other alternative medicines to FDA’s MedWatch Adverse Event Reporting Program:

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

Link to MedWatch Safety Alert and CDER Statement: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm570257.htm