As a parent, you have to put a great deal of trust in other people to keep your child safe. When they’re sick or have a condition that requires medication, you trust your pediatrician will prescribe the right drug in the correct dose. What would you say if the dose prescribed for your child is a shot in the dark because the drug wasn’t approved for use in children? And how do you know if using an off-label drug for your child puts them at risk?
When the FDA approves a drug, it’s saying that the drug is safe and effective for:
- Specific illnesses
- For the dosages stated
- For the age range the drug is approved for
It is called “off-label use” when a drug is prescribed for something other than it’s intended use, is prescribed at higher doses than stated on the label, or is used for a patient that is not in the identified age range.
There are no regulations against off-label use of medications. It’s left up to the judgment of the prescribing physician. The truth is, doctors prescribe medications for children off-label quite frequently. The FDA actually states on its website, “Most drugs prescribed for children have not been tested in children.”
The good news is this situation is improving because more studies involving children are being conducted. As studies are completed, the number of drugs being approved for use in children is increasing.
In the meantime, according to a study published in the professional journal Pediatrics, when a child is seen in a doctor’s office, approximately 19% of the time, they will end up leaving with a prescription for a drug that’s off-label. The question parents need to ask is: will using off-label drugs put my child at risk?
Azithromycin is an oral antibiotic commonly used by children. A multi-hospital study recently reported 9 % of children prescribed Azithromycin experienced what’s called a “serious adverse event.”
Use of drugs in this manner provides doctors with more treatment options. However, recommended dosages for these drugs are for adults. Using a drug on a child that’s intended for an adult is not just as simple as giving a lower dose. Many factors impact how a drug affects an individual.
The most common off-label drugs being prescribed for children include antibiotics, antihistamines, and antidepressants. Many of the drugs have been used for years, and doctors are confident the doses they’re prescribing are appropriate.
Often, dosages are often a best guess. On the FDA site’s page “Drugs and Children” Richard Gorman, M.D., chairman of the Committee on Drugs at the American Academy of Pediatrics (AAP), a member of the FDA’s Pediatric Advisory Committee, and a pediatrician in Maryland, says, “Even though the best and brightest pediatric minds have helped us establish dosages for children, we’re finding out that the dose is different than we thought in some cases. And that probably came as a surprise to most of us.”
The best way to be sure a drug prescribed for your child is safe? Ask questions.
- Is this drug approved for the illness my child has?
- Is it approved for my child’s age?
- Is this the normal dosage?
- If it is an off-label use, how long has the doctor been using it?
- What kind of side-effects have they seen?
- Is any research currently being done on this drug in the use of children?
Off-label use of drugs in children isn’t going away any time soon. Fortunately, increased research and being vigilant whenever your child is given a prescription will help keep your child safe.
Off-Label Drugs for Kids: Sources
FDA: Drug Research and Children
FDA: Understanding Unapproved Use of Drugs “Off Label”
Pediatrics
Pediatric Drugs