07/06/2012

Christina Elston

When your child is prescribed medication, ask questions and report problems. That’s the take-home message from a U.S. Food and Drug Administration (FDA) report on trends in pediatric prescription medications.

When your child is prescribed medication, ask questions and report problems. That’s the take-home message from a U.S. Food and Drug Administration (FDA) report on trends in pediatric prescription medications.

The report is part of the agency’s efforts to have more medications studied in children, says co-author Diane Murphy, M.D., of FDA’s Office of Pediatric Therapeutics. Following trends helps experts pinpoint areas where research is particularly needed.

Published in the journal Pediatrics this summer, the report notes that antibiotic prescriptions are on the decline, while prescriptions for ADHD drugs are rising. Murphy says health experts are delighted by the antibiotics trend. “Ever since I have been practicing medicine, we have been trying to convince parents not to request antibiotics for viral illnesses,” she explains. Conversely, the ADHD prescription increase was not a particular surprise. “We expected that some classes of drugs would go up, because they finally have been studied in children,” Murphy says.

Clinical trials in children are more complicated than those in adults, and there’s less potential profit from drugs targeted to kids, so drug companies have been reluctant to study their products in children. Legislation is turning the situation around, but many medications commonly prescribed in children still have never been formally studied.

One example is lansoprazole (brand name Prevacid), an anti-reflux drug prescribed 350,000 times to infants in 2010, despite the fact that no studies have been conducted in infants on its safety and effectiveness. Ann McMahon, M.D., also of the Office of Pediatric Therapeutics and co-author of the report, is heading up a study on use of lansoprazole in infants that likely won’t yield any results before 2013.

Meanwhile, she and Murphy have this advice for any parent whose child has been prescribed medication.

• Be aware that many medications still have not been studied for use in children. Because of this, doctors often have to prescribe drugs “off label,” and many medications have been used this way in kids for years.

• Ask whether the medication has been studied for treatment of your child’s condition in kids your child’s age. If it has not, ask whether there’s an alternative medicine that has been studied in children, and why your doctor wants to use this one instead. The “off label” medication could be a better fit or safer to use with other drugs your child is taking; or there simply may be no alternative.

• Ask about any potential side effects. Some could be minor, such as interfering with appetite or sleep. Others could be serious.

• Make sure your doctor reports any side effects or “adverse events” your child experiences to the FDA. Even when a drug has been studied for use in children, these reports help shape drug labeling and help keep doctors informed about potential problems.