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New UNC Study Shows Most Drugs Used for Neonates Unapproved

By Stephanie Soucheray

One of the hardest things for a parent is to watch their child be sick, and that difficulty is only amplified when their little patient is a newborn who’s landed in a neonatal intensive care unit (NICU).

Doctors who treat these infants have applied increasing skill over the past decade to improving outcomes for neonates, but they’re often working with limited information about what really works for very young babies, especially when it comes to the medications used on their patients.

A baby in a NICU under special lights to treat newborn jaundice.

A baby in an NICU under special lights to treat newborn jaundice. Photo credit: Michael Bentley, flickr creative commons

For example, every year half a million babies who spend time in a NICU will receive prophylactic doses of ampicillin and gentamicin.  These two powerful antibiotics ward off infections from immature immune systems and are the standard choice for hospitals across America.

There’s only one problem: Neither have been approved for use in neonates, or infants under 28 days old.

“Ninety percent of drugs used in the NICU are used off-label or off-patent,” said Matthew Laughon, a neonatologist at UNC-Chapel Hill.

Because most drugs are never tested in very young infants, neonatologists like Laughton have to make educated guesses based on anecdotal evidence on how to give drugs that have only been approved for use in adults or older children.

Laughton and his colleagues published what he calls an “awareness” article about this topic today in JAMA Pediatrics.

The study looked at federal legislation that encouraged new labeling information for pediatric patients, including neonates. While Laughton estimated there have been 300 to 400 label changes pertaining to older infants and young children, there haven’t been nearly as many labeling changes for neonates.

Laughton looked at two categories of drugs: new medicines used in NICUs that were developed after 1997 and older, established drugs. For each type, drug companies undergo an approval process for adults and then a similar process for children. But drug companies rarely complete trials that establish safety, efficacy and dosing for the smallest infants.

“We found that a little less than half of these drugs have safety or efficacy established for neonates,” said Laughton.

Reviewing the FDA database, he found 28 drug studies including neonates and 24 neonate labeling changes. Only 11 of the 24 labeling changes explicitly state the drug was approved for neonates and was safe and effective. Moreover, 13 of the 28 drugs studied were not commonly used in NICUs.

Without correct dosing information, neonates are at risk of getting too little or too much of a drug. They are also at a greater risk for side effects.

“If you take a drug and look at the adult dose, then try to do some calculation or division based on weight to give to infants, you’ll almost always get it wrong,” said Laughton. “Neonates have special physiologies and characteristics that make them difficult to study and dose correctly.”

Doctors treating neonates often have to make their best estimate as to the best dosages of many drugs.

Doctors treating neonates often have to make their best estimate as to the best dosages of many drugs. Photo credit: The Hudson Family, flickr creative commons

According to Laughton, “nearly 100 percent” of babies in the NICU are on some type of medicine during their hospital stay. The federal government is addressing this issue through the Food and Drug Administration Safety and Innovation Act (FDASIA), which was signed into law in July.

Laughton said the Pediatric Trials Network, which is based at the Duke Clinical Research Institute, will also look at neonatal drug use.

He said the study did not include common over-the-counter drugs given by parents, only hospital-administrated medicines.

Laughton said that parents also have a role in gaining correct safety information about neonatal drug doses.

“If parents volunteer for studies, it’s the only way we can get information,” he said. “It’s the only way we can move the field forward.”

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