Kids’ cough and cold medicines back in focus, FDA mulls over

New York, October 3: Once again the pleas of consumer groups and medical experts to pull out the cough and cold medications of kids from the market have become louder for the FDA to ignore the issue anymore.

The over-the-counter cough and cold medications available for the kids are becoming a growing source of concern with many demanding the drugs to be taken off shelves and be made available, if at all, only by prescription.

The reason being the lack of adequate research and information available on various ingredients of cough and cold medication for kids, resulting in almost 7000 kids being hospitalized every year in the country after having these medicines, with 33% of the cases resulting from medication taken without supervision.

Millions of cough and cold medications are being sold in stores across the nation, despite the warning of FDA last year against the medicines being given to below 2 year olds as they may have life threatening side effects.

The Food and Drug Agency now plans to completely ban companies from marketing products targeted at children. It also plans to instill stricter packaging and labeling standards as well. The step which would be quite welcomed by the medical experts and consumer groups might not be taken that easily by the drug brands in the market.

As per FDA estimates, there are over 800 cough and cold medicine brands available in the market today. The market research done by Information Resources firm confirms further that together, these brands sell over 95 million pediatric cough-cold medicine packs annually.

"A lot of people don't know that the FDA has never required companies to show their products are effective," said Paul Brown, government relations manager at the National Research Center for Women and Families.

Urging the FDA to take all the cough and cold medications for kids under six off the market, Joshua Sharfstein, MD, the Baltimore City Commissioner of Health, further asked for a recall of all these packages on the shelves of stores currently.

"Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," he added.

The move involving such drastic steps like recalling and providing the ‘prescription-only’ status to the cough and cold medications would mean a lot of money down the drain and loss in sales too, making the whole thing quite expensive to the heath care system.

This is a matter of concern for various organizations involved in trade of these medicines, one of them being Consumer Healthcare Products Association.

"The cost to the health system would be enormous," said Linda Suydam, president of the Consumer Healthcare Products Association.

While the companies mull over the losses they might incur due to the recalls and ban on their products, experts are quite clear that since the cough and cold medications for children actually do not have much of an effect on the cough and cold problems, which get better on their own anyway as time passes, it is not wise to give these drugs to the children, especially when they are known to have ill effects.

“In the absence of evidence of efficacy, any risk associated with these drug therapies is unacceptable," said David Bromberg, MD, a pediatrician from Frederick, Md., who testified on behalf of the American Academy of Pediatrics.

With fears that the recall might lead people to shift to adult medications for children, further worsening the situation, the consumer groups plan to educate people on the use and misuse of these medicines, before the FDA takes any concrete steps in the matter.