(Reuters Health) - Two-thirds of newborns in Europe who received common medicines were exposed to a potentially dangerous substance in the medication, according a new study.
The study did not look at whether the babies were actually harmed, only if they had been exposed to excipients - inactive substances included in many products - that have been linked to toxic side effects in newborns.
“Many of these potentially harmful ingredients of medicines are essential for the stability and safety of the medicine, for example by making the drug dissolve or stopping bacteria from growing in the medicine,” or they may extend a drug’s shelf-life, said lead author Dr. Georgi Nellis of Tartu University Hospital in Estonia.
The study team found some regional differences in how many babies were exposed to each of the eight excipients examined, which suggests that alternative versions of some drugs are available, they write in BMJ.
It may be impossible to give a medicine without an excipient, but in some cases they remain in a medicine because no one has tried to remove them, Nellis told Reuters Health by email.
The researchers studied data on newborn medication administration in 89 neonatal intensive care units (NICUs) in 21 European countries for one day in 2012. They focused on potentially harmful excipients linked to side effects ranging from kidney and liver dysfunction to nervous system depression and diarrhea.
The additives were: parabens, polysorbate 80, propylene glycol, benzoates, saccharin sodium, sorbitol, ethanol and benzalkonium chloride.
Very high doses of these substances can cause serious, even fatal, harm, but neonatal medicines have much lower doses, Nellis said.
“Excipients have been given to many millions of neonates with very few clear-cut cases of harm,” he said. Still, their long-term effects need more research, he added.
In all, 726 newborns received 2,199 prescriptions for 562 products containing 246 active ingredients, the authors found.
Babies born more prematurely tended to receive more medications.
Only 27 percent of medications contained one of the excipients, but the medications are common enough that 456 of 726 newborns were exposed to at least one.
Infants were most often exposed to parabens, a class of preservatives also found in cosmetic products. Less than ten percent of babies were exposed to sorbitol, ethanol or benzalkonium chloride.
Excipient-free medicines are not always available, and rejecting some of them could do more harm than good, but if formulations without them are available they should be used, Nellis said.
“Our paper shows that quite a few excipients could be avoided by using different versions of the same medicine,” he said.
The situation is likely similar in North America, he said.
“Doctors should be made aware if any (excipients of interest) are in the products they are prescribing so they can make informed decisions and also in case of any adverse events,” said Jenny Walsh, a pharmaceutical consultant on pediatric product development in Nottingham, U.K. “They should use their clinical judgment regarding what medicines to administer,” she said.
Walsh, who spoke to Reuters Health by email, was not part of the new study.
“At present, and at least in my hospital, excipients in the different products is an issue that is part of the evaluation when we have to make decision on product choices,” said Dr. Karel Allegaert, a neonatologist at UZ Leuven hospital in Belgium, who also was not part of the new study.
“The results of this study should be concerning to hospitals that buy medicines,” Nellis said. “They may be able to avoid using medicines that contain potentially harmful excipients.”
“Parents should not be concerned,” he said. “The medicines that babies are given do not appear to cause any harm and are only given if the benefits clearly outweigh any potential harms.”
SOURCE: bmj.co/1yy5Zkh BMJ, online April 8, 2015.