A discussion of OTC medications, their adverse effects on children, and why drug companies have voluntarily changed the labeling.
On October 7, 2008, the president of the Consumer Health Care Products Association announced that makers of over-the-counter (OTC) cough and cold medications would voluntarily change the labeling on those products to indicate that they should not be used for children less than 4 years of age. This was the most recent victory, following filing of a petition to the Food and Drug Administration (FDA) in March 2007 by 14 Maryland pediatricians1 calling for an end to the use of OTC cough and cold medications for children less than 6 years of age.
The petition highlighted both the risk of overdose and attendant adverse effects, as well as the lack of efficacy of these products in children. They cited, in particular, the deaths of four Maryland toddlers linked to cough and cold medications.
Just six months after that petition was filed, in October 2007-and days before an FDA advisory committee meeting on the subject-the makers of 14 OTC preparations intended for use in children less than 2 years voluntarily withdrew those products from the market.
The October 7 announcement by pharmaceutical companies that their labels will henceforth warn against OTC cough and cold medication use in children less than 4 years comes on the heels of the announcement of a year-long FDA review of these products, which began with public hearings just a week earlier. Previous published studies have found little to no benefit from use of antihistamines, decongestants, cough suppressants, expectorants, or from combinations of these agents in children.
The reported adverse events have most often occurred because infants and children receive more than the "recommended" dose, because they receive more than one combination product containing the same ingredient, or because they receive a single product more often than recommended.
The imprecision with which many medications are dosed is highlighted in the clinical tip from Alvin Eden, MD, (p. 14 of this issue). Frequently these products are administered by parents without advice or recommendation from physicians, but, as Dr. Eden points out, pediatricians and pharmacists do not always provide precise instructions for parents even when they are consulted.
Pediatricians have known for decades that the estimated $286 million spent on OTC cough and cold medications for young children each year brings little to no relief, and potentially causes harm. The Centers for Disease Control and Prevention has reported that an estimated 7,000 children present to emergency departments annually because of ingestion of excessive cough and cold preparations.
Why has it taken so long for attention to be focused on ineffective, potentially risky products being used to treat self-limiting symptoms? Parents, understandably, have assumed that if pediatricians weren't objecting to the sale of these products, and if the FDA was allowing their sale with labeling explicitly suggesting an appropriate dose for infants and young children, they must be safe and they must work.
Congratulations to the Maryland pediatricians who filed the citizen's petition urging the FDA to investigate the safety and effectiveness of OTC cough and cold preparations. I'm just wondering where the rest of us have been all these decades.
1. The Baltimore Statement on the Use of Over-the-Counter Cough and Cold Medications by Children Five and Under. Available at: http://www.baltimorehealth.org/press/OTC%20statement%20-%20final.pdf. Accessed Oct. 16, 2008
2. Transcript of FDA Press Conference on Cough and Cold Medicine. Available at: http://www.fda.gov/bbs/transcripts/2008/coughcold_transcript011708.pdf. Accessed Oct. 16, 2008