MONDAY, Sept. 16, 2019 (HealthDay News) — When a child gets sick, doctors are increasingly relying on what’s known as “off-label” use of medications, a new study says.
Off-label use of a drug means that it hasn’t been specifically studied and approved for the condition, age group or weight of the person getting the prescription.
For example, kids with asthma may be prescribed antihistamines (approved for allergies, but not specifically for asthma), because they may have allergies that trigger their wheezing, the researchers noted.
The study found that doctors prescribed one or more off-label drugs for children in almost 1 out of every 5 office visits.
“Off-label doesn’t mean a drug is harmful. There’s often good evidence behind the use of off-label drugs,” said study senior author Dr. Daniel Horton. He’s an assistant professor of pediatrics and epidemiology at the Rutgers Robert Wood Johnson Medical School in New Brunswick, N.J.
“But sometimes there isn’t good evidence, so it’s important for parents to discuss with the child’s doctor what is known and not known about off-label drugs, so they can try to ensure that the benefits of a drug outweigh the risks,” Horton said.
Doctors often turn to off-label drug use because no alternative exists, the authors said.
“Historically, children have been excluded from clinical trials of medications. This left a large gap in knowledge. Over time, legislation and policies to require more research have been developed,” Horton said.
The study is being published in the October issue of the journal Pediatrics, available online Sept. 16.
Dr. Rudolph Valentini, chief medical officer at Children’s Hospital of Michigan in Detroit, agreed that drug trials in children can be challenging.
He said sometimes parents don’t want their children involved in drug research trials. Another issue, he noted, is that “some diseases are just less common in children,” such as high blood pressure. Valentini was not involved with the new study.
Horton and his colleagues used nationally representative surveys from doctors’ offices, including about 1.74 billion visits for children under 18. During these visits, 18.5% of children were given a prescription for one or more off-label drugs.