FDA: Herbal Remedy Linked to High Lead Levels, Developmental Delay in Child
The Food and Drug Administration (FDA) is alerting parents and caregivers not use Balguti Kesaria Ayurvedic Medicine due to the risk of lead poisoning.
Balguti Kesaria (or Kesaria Balguti) Ayurvedic Medicine is an herbal remedy marketed for use in infants and children for various conditions such as rickets, cough and cold, worms, and teething. According to the product packaging, the product claims to help with digestion and bowel movement and improve the immune system.
The risk of lead poisoning was initially communicated by the North Carolina Division of Public Health who tested the product and found high levels of lead. In addition, the Michigan Department of Health and Human Services notified the FDA that two children were found to have high levels of lead associated with the use of this product. The families of the children affected stated that they had the product mailed to them from India. At this time, the FDA has received one report of developmental delays in a child who was administered this product.
The Agency urges parents and caregivers to stop giving the product to children and to consult a healthcare professional. Balguti Kesaria is sold online and made by different companies, including Kesari Ayurvedic Pharmacy in India. The product has also been mailed or brought into the United States. Healthcare professionals are asked to report any adverse events related to this product to the FDA's MedWatch Adverse Event Reporting Program.
For more information visit FDA.gov.