An Ayurvedic medicine labeled as a treatment for rickets, cough and cold, worms and teething in infants has been linked to lead poisoning, according to the Food and Drug Administration.
Labeled as Balguti Kesaria or Kesaria Balguti, it is manufactured by multiple companies in India and sold online in the U.S. The package instructs caregivers to grind the product to give to infants.
Its use has been linked to at least one adverse event report of high levels of lead and developmental delays in a child.
The FDA was made aware of the lead risk after the North Carolina health department tested samples of the product for lead. The Michigan health department also reported concerns of high lead levels in two children and found lead in its own product tests.
Pediatricians are urged to advise patients to stop using Balguti Kesaria Ayurvedic Medicine. There is no safe level of lead exposure in children, according to the AAP policy Prevention of Childhood Lead Toxicity (http://bit.ly/2vIiXiY). Children with blood lead levels as low as 5 micrograms per deciliter have shown lasting decreases in cognition.
Report adverse events to FDA MedWatch at www.fda.gov/Safety/MedWatch/ucm2005699.htm or download and fax reporting forms to 800-332-0178.