The U.S. FDA is rumored to be considering a ban on OTC cold and cough medications for young children. What are the implications?
According to a barrage of news reports last week, indications are that the FDA is considering strong advisories against the use of cold and cough preparations containing decongestants and antihistamines in children. These reports come on the heels of the FDA Public Health Advisory released August 15, 2007 stating that the agency would review safety and efficacy data in these medications.
Per the Wall Street Journal: “On Oct. 18, the FDA plans to hold a public meeting of a group of outside advisers to examine the safety and effectiveness of over-the-counter cough and cold medicines for babies and young children… On Friday, in advance of the meeting, the agency unveiled in-depth reviews of the issues, by its own experts and some other groups. Though the FDA hasn’t come to a final conclusion about how to deal with the drugs, a number of the reviews echoed alarm bells that doctors had earlier raised. Agency safety reviewers wrote that an analysis suggested that the use of some of the medications has been associated with serious side effects and some deaths in patients younger than 6 years old. They also noted that the drugs haven’t been proven to work in children. The FDA said Friday it had 54 reports of deaths in children linked to decongestants containing the ingredients pseudoephedrine, phenylephrine and ephedrine from 1969 to Sept. 13, 2006, and 69 reports of deaths linked to antihistamines with the ingredients diphenhydramine, brompheniramine and chlorpheniramine. The agency said the bulk of the reports were in children younger than 2. Also, a number of the deaths occurred in children who had gotten overdoses.”
I think that most pediatricians (holistic or not) would agree that OTC cold meds are overused in children. In fact, it’s one area where holistic and conventional pediatricians concur. The data is overwhelming that, under the age of 2 (and for many children under 6), cold and cough medicines simply don’t work. I discuss colds and coughs with parents as part of the natural course of childhood – they happen frequently, rarely are associated with significant illness, and are part of the way our immune systems learn to mature to fight infections and not ourselves (the idea of immune regulation balance). I understand that we don’t want our kids to suffer, and there are herbal and homeopathic remedies that could be used with potentially fewer adverse effects. Though in the case of botanical remedies, we truly have little safety and efficacy data, too. I advise families to hesitate against “symptom-treatment” substitution with herbs for OTC meds; it’s usually better to go the old fluids-and-rest route. There are other CAM modalities (chiropractic, massage, acupuncture) that some use to help with cough and cold symptoms. The general public perception is that these therapies have low potential for adverse effects, though this is not scientifically accepted fact in conventional medical circles.
Regarding safety, the issue is somewhat murky. The CDC issued a report in January 2007 detailing the mortalities and morbidities potentially due to OTC medication use/overdose. This report notes that in 2004-2005, “an estimated 1,519 children aged <2 years were treated in U.S. emergency departments for adverse events, including overdoses, associated with cough and cold medications” and makes note of the “deaths of three infants aged <6 months in 2005, for which cough and cold medications were determined by medical examiners or coroners to be the underlying cause.” These are, of course, grave concerns. But serious questions remain. What percentage of adverse effects were due to improper dosing amount or frequency? What is a safe dose? (Answer – no one knows, it’s never been studied). Of these adverse effects (probably under-reported, as are most adverse effects), what is the percentage of total doses given in the U.S. population surveyed at that time? According to the New York Times, “A 1994 study found that during one 30-day span, more than a third of the nation’s 3-year-olds were estimated to have been given over-the-counter cough and cold remedies.” This is probably an underestimate. Millions of doses of these medicines have been given to children over decades of use. Does this make it safe? No, and I absolutely agree we should be extremely cautious in the use of cold and cough medicines in ALL children (not just the youngest). Is diphenhydramine (i.e. Benadryl®), probably the most commonly-used antihistamine in children, to be outlawed? I think that’s not only over-reaching, it’s stupid. Perhaps it’s not terrific for cold symptoms, but it can be a crucial treatment for allergic reactions. There are no simple solutions here, and the FDA’s findings will have tremendous clinical and economic impact. I think we need to advocate for a calm, rational approach to these concerns. Stay tuned.