Giving Newborns Medicine is a Dangerous Guessing Game. Can we make it safer?


Medication for newborns is rapidly becoming a growing concern globally. About ninety percent of drugs administered to newborns (premature and full term infants less than twenty eight days old) are not approved by the Food and Drug administration (FDA). This means that medication given to infants have not been tested for correct dosage, safety and ho effective they are.

This is mainly caused by the fear of testing drugs on babies and the hesitation of parents to enlist their newborns for drug testing. Pharmaceutical companies while trying to avoid the risk of liability which may result from fatal mistakes in the tested babies are also reluctant to invest huge amounts of money into researching about drugs for infants because it is such a thin market.

Dr. Jonathan Davis, chief of newborn medicine, Tufts Medical Center says that admitted infants to the neonatal intensive care unit receive about sixty medication in their first month of life. Dr. Davis is presently conducting several clinical trials on newborns in his NICU. The FDA also launched two global efforts to encourage clinical trials in infants.

Most treatment prescribed by doctors for infants are usually done based on experience and how these drugs have been administered to adults. They simply dilute the dose and give it to babies which has led to disasters in the past.
The way infants absorb, metabolize and excrete drugs are different from the way adults absorb, metabolize and excrete drugs. This means prescribing drugs based on how it has worked in adults should be totally avoided when it comes to prescribing them to babies. This technique has led to several deaths in both premature and full term babies.

The Pediatric Research Equity Act of 2003 and the Best Pharmaceutical for Children Act of 2002 are two large legislative efforts to increase pediatric drug studies and were made permanent laws in 2012 with the passage of the FDA safety and Innovation Act.
These Acts have improved further studies into pediatric drugs and resulted in six hundred and fifty one drugs with revised labelling for pediatric patients.
These laws have still not been adequate enough to cover new born babies, only twenty four drugs had their labels revised which either showed that they were not to be used for infants or there were safety issues. These drugs do not fall into the category of recently used drugs according to an analysis of the NICUs carried out in the United States in 2017.

Despite the urgency and criticality of these issues, there has been no major change or research into finding medicine that have been proven to be safe for newborns. The National Institutes of Health initiative invested largely into a study that covers drugs in children but recently ran out of funds while other pharmaceutical companies avoid such studies because of constraints such as; limited blood samples, fragility and the possibility of causing permanent injury in the tested newborns.
With continued awareness and sensitivity to the issue, doctors would still have to continue based on guesswork in administering medication until an alternative arrives.

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