Most of the drugs that are administered to newborns have not been approved officially.

This is a global issue faced by paediatrics healthcare providers worldwide, and has been compounded by the unwillingness of big pharmaceutical companies and researchers to test drugs on babies due to their inherent vulnerability.

90% of medications not FDA approved for newborns

One wrong step, and the risk of mortality - and its associated costly liability lawsuits - escalates manifold. These risks and barriers prohibit major pharmaceutical corporations, researchers, and parents and doctors, alike from enrolling newborns into clinical trials.

This chronic lack of participants - one of the biggest barriers to clinical trials’ success - thus hampers the ability of drugs gaining their proper approval. As such, an estimated nine in ten medications administered to newborns are currently unapproved by the United States Food and Drug Administration (FDA) for use in neonates.

Such unapproved drugs have not been adequately tested for safety, dosage, and effectiveness.

Despite this lack of medical knowledge, Dr. Jonathan Davis, chief of newborn medicine here at Tufts Medical Center, said that, “… infants admitted to a neonatal intensive care unit may receive up to 60 [different] medications in their first month of life.”

When things go badly, who is to blame?

“Infants are not tiny adults and should not be given drugs as if they were,” said Catherine Sherwin, division chief of paediatric clinical pharmacology at the University of Utah School of Medicine.

She added that, although we know that newborns absorb, metabolise, and excrete drugs differently than adults, “… we haven’t done the studies to know exactly what those differences are. We just know they’re different.”

Indeed, due to the trial and error nature of most medicine dosages for newborns, and lack of medical knowledge about these drugs’ interactions in the newborns body, there have been numerous instances of drugs that were administered to newborns that resulted in death.

Dating back to the 1950s, one case detailed the sudden deaths of premature babies due to an overdose of the antibiotic chloramphenicol. Infants have also reacted adversely to a seemingly neutral substance - the preservative benzyl alcohol used to flush catheters.

Another preservative, propylene glycol, present in a multivitamin administered orally to premature infants in a dose intended for adults has resulted in deaths.

These unfortunate deaths occurred as doctors often make medication dosage decisions by scaling down from how medications are used in adults. “We take it right out of the vial of an adult drug, dilute it down, and give it to the babies,” said Davis.

Conflicted by the lack of treatment choices facing newborns who are ill, doctors often do not inform parents that the drugs used in their children have not been reviewed by the FDA for their safety and efficacy.

“There wasn’t much choice,” said one mother, whose infant was in the Tufts NICU. Her child was administered with unapproved drugs ranging from morphine to antibiotics.

Potential solutions in the pipeline

To combat the issue, there has been a FDA-funded nonprofit that has launched two global schemes to kickstart clinical trials in infants. The leader of one such initiative, the International Neonatal Consortium (INC), is none other than Davis.

He said, “we can’t be certain which drugs, in which doses, to use when,” and added that “We’ve got to do something.”

He argues that the current scheme of trial and error cannot be sustainable in the long-term, as each doctor’s decision is essentially an uncontrolled and unapproved study with a sample size of one. In addition, details of the doctor’s actions will not be recorded into medical literature, and not be subjected to peer-review.

Notwithstanding the benefits, he acknowledges the challenges that come along studying the medication’s interaction in neonates, but argues that this should not be an excuse to avoid research altogether.

At the National Institute of Health, an initiative that allocated US$25 million per annum is risking termination after financial supports ceases this year.

Further monetary support would be hard to come by due to the fear of litigation should things go south. These injuries have, in the past, been awarded large malpractice compensations - setting a legal precedence for future litigations of the same kind.

This has deterred any potential research regarding neonates. To boost research efforts, legislation would have to be enacted to encourage research, in addition to a liability waiver should anything bad happen. MIMS

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