Chemicals in Some Meds Risky for PreemiesJan 21, 2009 | Parker Waichman LLP
Some routine chemicals found in medications are posing dangerous risks for premature babies. According to research conducted by a team from the University of Leicester, chemicals added to medications to improve taste, longevity, and absorption could prove harmful to babies, reported Science Daily. The research was published in advance of print in the Fetal & Neonatal Edition of Archives of Disease in Childhood.
The researchers studied harmful substances in the liquid medicines to which premature babies are exposed, specifically nondrug ingredients—so-called excipients—in such medications, said Science Daily. The study was 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.
Science Daily said that ethanol, sorbitol, and Ponceaau 4R, which has to do with coloring, were the chemicals generally involved and that preemies are exposed to these dangerous substances in amounts equal about one and a-half quarts weekly. Said 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.”
Dr Pandya added that, “Both the UK Government and the European Union have recently passed legislation to incentivize drug companies to develop better medicines for children.” OnMedica pointed out that the research revealed that in some instances, the chemicals were in levels that exceeded those recommended for adults; that quality checks on medications only occur in the adult population; and that there is minimal data on excipient safety, especially in the pediatric population. PhysOrg explained that the researchers noted that children’s medicines have to cater to a wider age range than adult medications, which makes it difficult to create drugs by age group and added that, in some cases, excipients are a necessary component of the medications.
The team analyzed the type and content of liquid medicines given to 38 babies for whom all drug records were available, who were born after 30 weeks of pregnancy or less, and who weighed under 1500 grams—which is about 3.36 pounds—at birth said OnMedica. The babies were treated for between 2.5 and nine weeks, and received an array of treatments including iron and vitamin drops, Furosemide (commonly known as Lasix, the diuretic used in cardiac patients), and Dexamethasone, an anti-inflammatory. It was found that the babies were generally exposed to 20 different excipients, including ethanol, which can be found in both iron and Furosemide as well as propylene glycol, which is found in Dexamethasone. Both chemicals are known to potentially cause nerve damage. Also, the UK Food Standards Agency has recommended the removal of Ponceau 4R—which can be found in the iron drops—over concerns about its effect on neurodevelopment and behavior.
“We feel it is important that the [medicines regulators] not only ensure that all manufacturers provide detailed labeling 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,” said Dr. Padya, according to OnMedica.