*This post first appeared on The PediaBlog on August 10, 2017.


FDA Warning On Supplements


This week the U.S. Food and Drug Administration issued a warning [updated 11/1/17] about a product I had never heard of before, though I suspect some parents have:

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…

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…


Pharmacologist Da Hee Han explains how this herbal “remedy” has been used in children in the United States and around the world:

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 FDA warning reminds us of the dangers of lead exposure in childhood and the fact that there is no safe level of lead in the bodies of infants and children (a subject we’ve covered many times previously on The PediaBlog):

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.


Ayurveda, Wiki tells us, comes from the Sanskrit meaning “life-knowledge”:

Ayurveda or Ayurveda medicine, is a system of medicine with historical roots in the Indian subcontinent. Globalized and modernized practices derived from Ayurveda traditions are a type of complementary or alternative medicine. In the Western world, Ayurveda therapies and practices have been integrated in general wellness applications and in some cases in medical use.


If you or someone in your family takes nutritional supplements (vitamins, minerals, herbs, oils, amino acids), herbal remedies, or another product that is (illegally) marketed to treat, diagnose, prevent, or cure diseases, then the FDA wants to warn you about some health risks you or a loved one might be taking:

Many supplements contain active ingredients that have strong biological effects in the body. This could make them unsafe in some situations and hurt or complicate your health. For example, the following actions could lead to harmful — even life-threatening — consequences.

> Combining supplements

> Using supplements with medicines (whether prescription or over-the-counter)

> Substituting supplements for prescription medicines

> Taking too much of some supplements, such as vitamin A, vitamin D, or iron

> Some supplements can also have unwanted effects before, during, and after surgery. So, be sure to inform your healthcare provider, including your pharmacist about any supplements you are taking.


That last point is so important: Please tell your healthcare provider and pharmacist about any supplements you are taking. In fact, you should always have a list of medicines and supplements handy (there are apps for that) in case of emergencies, or when visiting the doctor for an annual checkup or appointment with a specialist. Chances are your primary care provider may have a positive (or, at least, neutral) view of complementary and alternative therapies; if they are clueless, that would be a good time to educate them. Just like I was clueless about Balguti Kesaria Ayurvedic Medicine, but now I know.


(Google Images)