US Experts Demand Removal of Cough and Cold Formulations for Children

by Gopalan on Sep 30 2007 12:33 PM

Cough and cold syrup for children? That is so much hogwash. Ban their over the counter sale. They could dangerous, experts have told the US Food and Drug Administration (FDA).

They say that there is little evidence that these medicines are effective in young children, and there are increasing fears that they may be dangerous. From 1969 to 2006, at least 54 children died after taking decongestants, and 69 died after taking antihistamines, a safety review report by them said.

(Antihistamines are a class of drugs used to treat allergic reactions.)

For its part the Consumer Healthcare Products Association wanted the FDA to consider mandatory warning labels saying that they should not be used in children younger than 2. Many cough and cold medicines now advise parents to “consult a physician” before use in such children.

Despite the industry’s recommendation, many companies — including such giants as Johnson & Johnson — continue to sell cough and cold medicines with “infant” in their titles and pictures of babies on their labels.

Previously a study by the Centres for Disease Control and Prevention had found that more than 1,500 children under the age of 2 had suffered serious health problems between 2004 and 2005 after being treated with common cough and cold medicines.

Current figures on the medicines’ sales and use are not available, but in 1994 researchers reported that more than a third of all 3-year-olds in the United States were given over-the-counter cough and cold preparations in one 30-day span.

In a typical drugstore, more than 30 separate cough and cold preparations are marketed to parents for use in children.

Meanwhile on Friday the FDA warned the makers of nearly 200 unapproved prescription medicines containing the pain-and-cough-relief drug hydrocodone that by Oct. 31 they must stop making these products for children under 6.

Makers of all other unapproved hydrocodone products have until Dec. 31 to stop making them.

Hydrocodone is a narcotic that is widely used to treat pain and suppress cough. There are seven FDA-approved prescription cough products containing hydrocodone, and doctors can continue to write prescriptions for those.

There are thousands of such unapproved drugs on the market. Indeed, an estimated 2 percent of all prescriptions are written for unapproved products. Most have been around for decades, and the FDA is gradually forcing their makers to either get official approval or stop selling them.

In the case of pediatric over-the-counter medicines, the agency decided decades ago that drug makers could market the medicines for children even though they had only been tested in adults. Back then, it was assumed that children’s bodies were simply smaller versions of adult ones.

That assumption has proven untrue, it is pointed out. Indeed, a growing number of studies suggest that cough and cold medicines work no better in children than placebos. Allergy Drugs More Harmful Than Helpful for Chronic Ear Inflammation