On October 12th makers of cough and cold medicines pulled their drugs targeted for babies and toddlers from store shelves. Then the following Friday an advisory panel for the Food and Drug Administration voted to ban over-the-counter cold products targeted for children under six years old. The votes to ban the over-the-counter products for 2 years of age and younger was 21-1, while the vote to ban over-the-counter products for ages 2-5 years of age was 13-9. So we most likely won’t see a ban for drugs for children over the age of 2, because the agency is likely to ignore such a close vote according the New York Times.
The ban is suggested, because all 11 studies reviewed by the panel report that the medicines don’t work and in some rare cases cause serious harm. Also, the drugs were only tested on adults and assumed to be safe in children. Researchers have since found that some medicines react differently in children than adults.
A ban might not even take place at all. Dr. John Jenkins, director of the FDA’s office of new drugs, in an Associated Press article says, “If the agency chose to restrict use in children 6 and under, that won’t necessarily lead to a ban on the products. It might lead to labeling that says ‘do not use.’”
Also a ban may not happen for a while, because of the red tape of the FDA and the manufacturers will fight the ban according to the New York Times.
The panel’s patient and family representative, Amy Celento of Nutley, N.J. in an AP article said that she fears that parents will administer adult products to their children because they work for them or feel they work for them.
In the same AP article, “the panel also recommended drug makers provide standardized droppers with their liquid cough and cold medicines. Experts had told the panel the sometimes hard-to-use dosing devices contribute to parents unwittingly overdosing their children.” I agree! It takes me about five tries to get the medicine in the dropper right at .4 or .8. Better droppers would be nice!
There is a lot of talk in the media about these medicines and the FDA is taking no action right now. The advisory panel has only made suggestions to the FDA.
If the reports claim that the medicines don’t work, then a ban is not a loss to parents. Although, I know one parent who claims the medicines work for her four children. My daughter is only five months old, so I wouldn’t consider cough and cold medicine right now. She had her first cold last week and I have given her some children’s Tylenol when she had a fever and on the nights she was extremely uncomfortable. I have also made sure to feed her often, so she gets lots of liquids to break up the mucus. If needed, we also use a warm humidifier during the night.
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Yesterday the U.S. Consumer Product Safety Commission announced a recall of Bumbo Baby Sitter seats, because there have been reports of children falling out of them and three children had skull fractures.
