Manufacturers Withdraw Cough and Cold Medications for Children Under Two

Contributed by Jim Wilde MD

The country’s major pharmaceutical companies announced in October of 2007 that they had voluntarily withdrawn from the market all cough and cold medications for children under two years of age. This was a major victory for evidence based medicine. For years a growing number of pediatricians have discouraged the use of these medicines in very young children for two reasons: first, they have never been shown to be of any benefit in this age group; and second, there is mounting evidence that they are harmful.

Medications that work for older patients don’t necessarily work for young children. Children have different anatomy and physiology and response to medicines. The antibiotics used to treat pneumonia in adults are different from those used to treat young children. Codeine containing cough medications can be beneficial in adults, but in children they offer no additional benefit over dextromethorphan, the “DM” component of common cough medications. Cold medications containing a combination of antihistamines and decongestants relieve stuffiness and congestion in adults, but they have no effect in toddlers or infants.

Getting this message out has been an uphill battle, in part because of clever marketing by the pharmaceutical companies. Astute observers recall that at the end of televised advertisements for these products, usually after several images of mom lovingly tending to her sick preschooler, viewers are briefly informed that they should consult their doctor for dosing in children under two. Why are these messages included? Because there are no dosing recommendations for children under two. Dosing in this age group is pure extrapolation from data in older patients, with no evidence to support it.

Pediatricians went on the offensive in the Spring of 2007 after the CDC reported several deaths in infants due to common cold medications. Soon after, a coalition of public health authorities and academic physicians in Baltimore petitioned the FDA for a review of the original approval for cough and cold medicines in children. They argued that the FDA violated its own rules when they gave this approval in the 1970’s. The rules require that new drug approvals must include evidence that the medication is safe and effective. There was no evidence for either in infants and toddlers.

It appears that the pharmaceutical industry realized they were fighting a losing battle, and decided to voluntarily remove their products from the market rather than risk a public relations disaster.

Many parents will react with dismay to these developments, wondering what they should give their infant or toddler when they have cough, congestion or runny nose from cold or flu. An antibiotic? Not only are antibiotics useless against the viruses that cause colds or flu, they can actually be harmful. Up to twenty percent of young children who are given antibiotics will develop complications including diarrhea, GI upset, body rash, diaper rash, or Thrush. How about an antihistamine? Vitamin C? Zinc lozenges? Echinacea? The honest answer is that none of the above has been proven to help, although there is widespread misperception that they do because children usually improve after using them for three or four days. The fact that children also improve in three or four days without these medicines is lost on many in the general public. Don’t expect the pharmaceutical industry to clear up the confusion.

When parents are given a prescription for their child, they reasonably assume that the medication will help. Good physicians educate their patients about self-limited illnesses like the common cold rather than recommend ineffective medicines.

Cough and cold medications may relieve runny nose and congestion in adults and children beyond the toddler age group. Use of bulb suction and saline drops to keep the nose clear of sticky mucus will allow infants with colds to breather easier. Fever lowering drugs like Tylenol or Motrin will provide temporary relief from fever, headache, or body aches in all age groups. Otherwise chicken soup, bedrest, and time are the best remedies for young children with colds.

Published as a guest editorial in the Augusta Chronicle October 24 2007

Posted on Monday, October 15, 2007 at 05:54PM by Registered CommenterAdministrator | CommentsPost a Comment