Pediatric Cough and cold medicine: Helping patients make sense of information from the FDA
Your 5-year-old daughter wakes up in the middle of the night, sniffling and coughing. You want her to feel better and help everyone in the house get back to sleep. So you give her a dose of over-the-counter cough and cold medicine. You have no qualms about doing so because the medicine has been approved by the FDA. But is giving this medicine really a good idea? The answer isn't exactly clear.
Rebecca Burkholder, JD, is vice president of health policy at the National Consumers League. She coordinates the League's work on healthcare issues including safe use of medication, patient safety, doctor-patient communication, and direct-to-consumer advertising. One of the issues she is currently focusing on is the safety of children's cough syrup and cold medicine.
Burkholder explains that the FDA is a government agency that's charged with making sure the medications we take — both prescription and over-the-counter (OTC) drugs — are safe and effective. The agency approves a new drug only after clinical trials have shown that its benefits outweigh its risks. But questions regarding safety can still arise after a drug has been approved and becomes widely available. When new data raises concern, the FDA needs to weigh the evidence and decide when and how much to tell the public. "It is a balancing act," Burkholder says, "to put information out there but without causing undue alarm."
Questions in the minds of the public about the safety of pediatric cough syrup and cold medicine stem from just such a balancing act. These medicines are intended to treat children's cold symptoms and make them feel more comfortable. They do not treat the cause of the symptoms or shorten the length of a cold. According to the CDC, each year about 7,000 children under the age of 11 go to hospital emergency rooms after taking cold and cough medicines. The CDC also reports that there have been a number of deaths in very young children as a result of them being given too much of these medicines.
While the risks of pediatric cold and cough medicine are becoming clearer, there is still confusion over the benefits. Burkholder says that even individual physicians may not agree on whether children should be given these drugs. In January of 2008, the FDA issued a Public Health Advisory recommending that OTC cough and cold products not be used for infants and children under two years of age. Then this past October, the FDA issued another statement supporting the voluntary relabeling of nonprescription OTC cough and cold medicines for children. The new labeling is to indicate the medicines should not be used for children under four years of age. At the same time, the FDA is continuing to evaluate information about the safety of these products for older children.
Burkholder, who with her colleague participated as an advocate for consumers in the FDA process of review, understands the difficulty parents may have sorting through the information and using the medications safely. Recently, we discussed ways clinicians might help parents make sense of what they see and hear and protect their children's well-being. Here are her suggestions:
Help parents understand and weigh risk and benefit information. Since all drugs have risks, the key question is whether these risks outweigh benefits. This is not always easy to determine as people vary in the level of risk they will accept. Also, the way risks and benefits are presented can influence a person's response to the information.
Here's an example. If two people out of twenty are at risk of developing a certain complication from a condition, and a drug reduces that risk to one out of 20, the benefit can be viewed in two ways. Stated in terms of a relative risk, the drug reduces a person's risk by 50 percent. However, the risk reduction when put in terms of an absolute risk is only five percent (a 10 percent risk without the drug versus a 5 percent risk with the drug). While 50 sounds better than five, in fact, both statements describe the same thing. Health consumers — in this case parents considering cold and cough medications — may need help understanding the kind of risk statement they are reading.
Talk about multiple-ingredient medications. Many cough and cold medications include antihistamines, pain relievers, decongestants, and cough suppressants. Parents need to be careful not to give their children drugs such as Tylenol along with multiple-ingredient cold medicine. Encourage parents to check labels for active ingredients so as to avoid giving children a double dose of a medication.
Burkholder also says that a common misconception about OTC medications is "If a little makes you feel good, a lot may make you feel even better." But more is not necessarily better and, in fact, could be harmful. Parent's may need help understanding the potential harm of such well intended mistakes.
Educate parents about dispensing medication.
Burkholder says that, in the middle of the night, parents may make "desperate calculations" and dispense medication incorrectly, for example by using a spoon that's too-large. She recommends talking with parents about how much medication to give and what measuring device to use. Ideally, dosage should be based on a child's weight or weight and age, not age alone.
Another important issue to discuss with parents is not "dosing down" adult medications. Burkholder and others are concerned about what will happen if all pediatric cough and cold medicines are pulled off the shelves. They fear that some parents will simply give their children smaller doses of adult medication, which could lead to a very dangerous situation.
Discuss the influence of advertising and marketing. Help parents appreciate the influence of marketing, such as OTC medication labels with pictures of teddy bears or blissfully sleeping babies. Also, parents may need to be reminded that the fact a drug is flavored in a taste children enjoy (like cherry or grape), does not necessarily mean it's safe.
Burkholder says that young children get about 6 to 10 colds a year. She recommends that clinicians talk with parents about less risky ways to manage symptoms such as getting plenty of rest, breathing steam, and drinking lots of fluids. When it comes to treating symptoms of the common cold, parents may need to hear that maybe their mother's advice was right.
Ways to learn more:
Rebecca Burkholder, JD is Vice President of Health Policy at the National Consumers League. To learn more about this organization, go to http://www.nclnet.org.
You can read the NCL's statement to the FDA on over-the-counter cough and cold medicine at http://www.nclnet.org/health/fda_otc_kids_10022008.htm.
Helen Osborne, MEd, OTR/L, is president of Health Literacy Consulting. She received two "Gold" 2008 Plain Language awards from NIH for her work on the NCI booklets "Radiation and You" and "Chemotherapy and You." Her column appears regularly in On Call. You can contact her by e-mail at Helen@healthliteracy.com.