Herbal remedies commonly used in infants without efficacy & safety guarantees: Study

By Dr. Ananya Mandal, MDMay 4 2011

According to a new U.S. government study parents commonly give infants teas or herbal supplements said to soothe “fussiness” even though there's no good evidence that the products work. The market is flooded with these teas and botanical products with ingredients like chamomile, ginger and fennel that are marketed for easing infants' tummy troubles, fussiness and sleep problems. However there is no evidence that these are effective and safe.

The new study published Monday, Dr. Yuanting Zhang and colleagues at the U.S. Food and Drug Administration (FDA) wanted to find out how common it is for parents to give infants tea or herbal products. The team surveyed more than 2,600 U.S. mothers, they found that 9 percent had given their baby at least one of those products in the first year of life. The finding comes from analysis of data collected in the Infant Feeding Practices Study II, a longitudinal survey of women from late pregnancy through their infant's first year of life, conducted by the FDA and the CDC between 2005 and 2007, according to the researchers.

The study is the first to study herbal tea and DBS use exclusively in infants, and yielded a much higher prevalence than earlier studies, including the 0.8% prevalence found among children in the National Health and Nutrition Examination Survey and the 3.9% prevalence found among children in the National Health Interview Survey.  The commonly used products used are teas with chamomile or other herbs said to soothe; gripe water, a botanical marketed for easing colic that includes ingredients like ginger and fennel; and “teething tablets,” which may contain ingredients like calcium and chamomile. Mothers reported that they used the products to help with their babies' fussiness, colic, digestion or teething, the FDA team reports in the journal Pediatrics.

Researchers have also reviewed 15 studies and reported in Pediatrics. They found scant support for using herbal extracts, sugar water or digestion-aiding “probiotics” for colic. Colic is seen in healthy babies who cry excessively. Colic is very common, and usually disappears after the first few months of life. Experts often recommend that parents try tactics like giving their colicky infants smaller, more frequent feedings, or more touch and attention. But there are no products known to ease colic.

These products are considered dietary supplements and since these are not regulated in the same way drugs are, they do not have to be proven safe and effective before they go on store shelves. They may also contain contaminants, like heavy metals, that could be particularly unsafe for infants, according to the FDA researchers. They add that there have been poisonings of infants and adults using traditional Indian Ayurvedic remedies tainted with lead. “Because the purity and potency of such supplements and teas are not regulated in the same way as pharmaceuticals, their administration concomitantly with medicines may cause drug interactions, and they may contain heavy metals or other contaminants,” the researchers wrote, adding that differences in physiology, metabolism and dose per body weight may make infants more susceptible to adverse events.

And even if the products are safe, Zhang's team writes, experts generally recommend that babies receive only breast milk or infant formula for the first 4 to 6 months of life. Giving babies tea or other liquids may dampen their desire for the nutrient-rich milk that they need. In general, experts recommend against giving infants any medications or supplements without the advice of a pediatrician.

“Health care providers should recognize that infants under their care may receive a wide variety of different supplements and teas,” said Yuanting Zhang. Clinicians should be aware of potential medication reactions and adverse events, the researchers urged.

The study was not nationally representative, according to the researchers, and therefore, the findings are not to be generalized to the overall U.S. population. The researchers also noted that older non-Hispanic white mothers of high socioeconomic status were overrepresented.