Babies Exposed to Harmful Toxins in Liquid Medicines
According to new research, published in Fetal & Neonatal Edition of Archives of Disease in Childhood, premature babies and infants who must receive liquid medications may be exposed to harmful toxins that are routinely added to improve taste and absorption.
The findings show that premature babies and infants may be receiving liquid medications that contain substances tested on adults, but the chemicals, called "excipients", can cause nerve damage in premature babies and infants.
The study, led by Dr Hitesh Pandya, Senior Lecturer in Child Health in the Department of Infection, Immunity and Inflammation at the University of Leicester and Consultant Pediatrician at the University Hospitals of Leicester NHS Trust, found that the chemicals contained in liquid medicines given to babies, include ethanol, sorbitol and Ponceaau 4R (used as a coloring agent).The toxic effects are the same as giving babies three beers per week.
According to Dr. Pandya, "This study documents a worldwide problem. It shows that the collection of medicines given to babies may ultimately lead to them being exposed to harmful chemicals with the potential for short and long-term toxic effects. Our research highlighted this, and we are planning further studies on the chemicals to understand exactly what these effects might be. What our study hasn't done is find any direct evidence on the cause and effect of these chemicals and the medical problems that these babies might be being treated for."
The researchers studied liquid medications given to 38 babies. All of the babies had been born after thirty-eight weeks of pregnancy, and admitted to the neonatal intensive care unit of a hospital in England.
The study showed that the babies were exposed on a regular basis, to twenty different toxic substances including ethanol (found in iron and Furosemide) and propylene glycol (found in Dexamethasone). The chemicals in the liquid medicines have the potential to cause nerve damage in babies. Premature babies with lung problems were exposed to even higher levels of toxins as the resultant need for more intense treatment. The researchers noted that the maximum dose of Sorbitol for adults is 20 g/day-the level of sorbitol exceeded that deemed safe for adults in eighteen babies.
Dr Andrew Currie, Consultant at the University Hospitals of Leicester NHS Trust, was also part of the research team. He says parents should not panic, though there is a definite need for more research to find out the long-term toxic effects the liquid medications may have on babies. He points out that the chemicals are also contained in many foods. "It is often necessary that these chemicals are added to medications, and in the majority of cases it improves the way the drugs work, but we should be taking more of an interest in them and their effects. It is great news that Dr Pandya and his team will continue their research," says Currie.
The study highlights the need for improvement of studies from drug companies when testing medications given to infants. The difficulty lies in restrictions about testing drugs on small children. The researchers say they are in "close discussions with drug manufacturing companies about overcoming some of the practical hurdles that restrict performing drug trials in very small children".
In the meantime, the UK Foods Standards Agency has recommended removing the coloring agent Ponceau 4R from liquid medications given to babies, due to concerns about its effect on neurological development and behavior. They also say, "We feel it is important that the [medicines regulators] not only ensure that all manufacturers provide detailed labelling of the excipient content of their products but all lead action to determine whether existing practice constitutes a risk, and if so, how this might be dealt with."
The study clearly identifies an unstudied risk for babies who receive medicines containing potentially toxic chemicals routinely added to liquid medications to improve taste and absorption. Until further studies are performed, the long-term effects of those toxins will remain speculative.
Premature babies exposed to toxins in liquid medicines