In the News - Drug companies: No cold meds for kids under 4

Cold and flu season is starting. As such, talk about medicine for small children is making headlines.

I got a call from daycare one day about a month and a half ago that Willow had a fever and I had to come and pick her up. I couldn't bring her back without her going to the doctor and obtaining an "all clear" note. The next day we went to the doctor and she told us that Willow had what appeared to be a viral infection. I asked if we should give her something for it and surprisingly, the pediatrician said NOT to give her anything unless she appeared to be uncomfortable. She explained that the fever was her body's way of fighting the infection that she had and that giving her medication could slow down the process and only treats the fever, not the infection.

I thought this was interesting. In checking the news this week I saw the article Drug companies: No cold meds for kids under 4, and I remembered the doctor visit and thought I'd talk about it here!

Last week, the Food and Drug Administration (FDA) said NO to an all out ban on over the counter drugs for small children and infants, fearing that harm could come if parents used adult medications instead. According to the article FDA rejects ban on child cold medicines, a top government health official rejected the idea of an immediate ban on cough and cold medicines for young children, saying it might cause unintended harm.

Food and Drug Administration officials at a public hearing October 2, 2008 said they need to gather more data on whether over-the-counter remedies are safe and effective for children ages 2 to 6. Although leading pediatricians' groups are calling for the ban, the FDA doesn't see an immediate need. In the interim, they are seeking counsel from doctors, the industry, and consumers on the matter before making a final decision.

A recent Boston University study, Cough and Cold Medication Use by US Children, 1999–2006, found that in any given week these medicines are used by an estimated 10 percent of all children, with the biggest exposure among 2- to 5-year-olds. The study also found that Exposure was highest to decongestants (6.3%; mostly pseudoephedrine) and first-generation antihistamines (6.3%; most common were chlorpheniramine, diphenhydramine, and brompheniramine), followed by antitussives [cough medicine] (4.1%; mostly dextromethorphan) and expectorants (1.5%; almost exclusively guaifenesin). Additionally, they found that the use of cough and cold medications has declined from 1999 through 2006.

The industry who manufactures the medicines say that they have been used for decades and are safe for children under 2 years of age. However, it turns out that when the FDA set standards for cough and cold medicines some 30 years ago, no separate studies were done for kids. Additionally, cough and cold medicines send about 7,000 children to hospital emergency rooms each year with symptoms ranging from hives and drowsiness to unsteady walking. Low doses of a medicine are not likely to cause a problem; the main risk comes from unintentional overdoses. Because the same ingredients usually are found in different products, giving a child a cough syrup and a decongestant could inadvertently lead to an overdose.

But the industry isn't backing down siting that the Consumer Healthcare Products Association, which represents the manufacturers, says preventable errors are the problem, not the safety of the ingredients in the medicines. The industry is starting an educational campaign aimed at parents, doctors and day care providers on the importance of following directions and storing medicines in places where kids cannot get at them. The head of the industry group, Linda Suydam, says that "The data clearly show a majority of adverse events are direct result of misuse of our products".

Pediatricians are welcoming the move by the industry to add warning labels to their medicines for small children. "We are doing this voluntarily our of an abundance of caution," Ms. Suydam added. The new instructions will appear on products distributed for the coming cold season.

Pediatricians still support recalling the medicines for children under 6, and the Food and Drug Administration is studying their effectiveness for children under 12. But it could take a year or more for federal health officials to reach a final decision.

The industry is also expanding an educational campaign aimed getting parents to be more careful in giving their kids cough and cold medicines.

Parents should never:

• Give adult medicines to a child.


• Give two or more medicines with the same ingredients at the same time.


• Give antihistamines to make a child sleepy.
  

Parents should:

• Give the exact recommended dose, using the measuring device that comes with the medicine.


• Keep OTC medicines out of sight and out of reach.


• Consult their doctor if they have any questions.
  

I guess my pediatrician was right to be worried. I know it can be hard to see your child suffering. You want to help them to feel better. But I have also noticed that small children in particular are pretty resilient. Since colds typically last only a few days, they tend to brush them off for the most part. I mean, who wants to get in the way of play time?

Tune in tomorrow for Alternatives to Cold Medicine for helping your child feel better when they are sick!!