FDA warns of lead in an alternative OTC medication

The U.S. Food & Drug Administration recently reported that Balguti Kesaria Ayurvedic, an Indian over-the-counter medicine, contains significant amounts of lead. This compound is used for various infant and childhood complaints including coughs, colds, and teething. The Centers for Disease Control and Prevention says: “There is no safe blood lead level,” and that all sources of lead can cause illness and even death with very little in symptoms until harm has already been done.

The FDA initially learned about the risk from the North Carolina Division of Public Health after the product was tested and found to contain high levels of lead. It 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, according to a FDA press release.

Lead in traditional medicines is not a new problem. The lead can be introduced from the vessel the medicine was made in or it can be added on purpose because many traditional healers believe it helps heal various ailments.  In medications for children, it is sometimes added because it is sweet and makes the medication easier to give to children. Also, it is found in many pigments used to give the compound a better color.

I have seen it introduced to babies in herbal Chinese medications for colic, but it has also been found in East Indian, Indian, Middle Eastern, West Asian, and Latin American produced remedies. In general, avoid these remedies including “Gripe Water” unless the ingredients are clearly listed on the bottle and it is produced in the European Union or the United States. In fact, a medication produced in the European Union is better because they are strict about OTC remedies.

How do you know if an herbal of folk medicine contains lead? The CDC says you cannot without having it tested in a lab. Latin American remedies Greta and Azarcon (also marketed under alarcon, coral, maria luisa or rueda) have tested positive for lead, Ghasard from India, Ba-baw-san from China, and Daw Tway from Thailand and Myanmar (Burma).  This is by no means a complete list and many more names can be found on the CDC case management web site.

If you think your child or yourself have ingested a medication containing lead, call your doctor right away and get a blood test for lead.

Remember that “herbs,” “treatments,” “supplements,” and “tonics” are still medicines and you should be as cautious with them as you are with any prescribed or OTC “medicine.”