When your child is prescribed medication, ask questions and report problems. That’s the take-home message from U.S. Food and Drug Administration (FDA) experts on the heels of the latest report examining trends in pediatric prescription medications.
Diane Murphy, M.D., of FDA’s Office of Pediatric Therapeutics, explains that the report is part of the agency’s effort to increase the number of medications that have been studied in children by targeting areas for further research.
The report, published June 18 in Pediatrics, noted that the number of prescriptions for antibiotics had fallen, while prescriptions for ADHD drugs were on the rise. Murphy, one of the authors, says experts were delighted at 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. And the increase in ADHD prescriptions was not a particular surprise. “We expected that some classes of drugs would go up, because they finally have been studied in children,” she says.
Because clinical trials in children are more complicated than those in adults, and there is less profit to be made on drugs targeted to kids, 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. “Even though we’ve made great strides, we’re about half way,” Murphy says.
One example mentioned in the report 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 to show its safety and effectiveness. Ann McMahon, M.D., also of the Office of Pediatric Therapeutics and another author of the report, is heading up a study on use of lansoprazole in infants – a complicated undertaking that won’t likely yield any results before 2013.
Meanwhile, Murphy and McMahon 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 children your child’s age. If it has not, ask whether there is 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 safer to use with other drugs your child is taking, or a better fit for some other reason. Or there may be no alternative.
• Ask whether there are any side-effects you should look out for. 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 FDA. Even when a drug has been studied for use in children, these reports help shape labeling of drugs and help keep doctors informed about potential problems. “These studies [in children] are often small, and they don’t pick up some of the more unusual things,” McMahon says. In the case of one ADHD medication, “hallucinations” was listed among possible side-effects, but not featured prominently on the label. Once FDA began receiving reports, the labeling was changed to make sure parents were aware that if children taking the medication began to hallucinate, reducing the dosage or discontinuing the medication would correct the problem.
And, of course, don’t hesitate to contact your doctor if you are worried about symptoms your child experiences while taking medication.