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Kids' Cough & Cold Remedies Under Fire

FDA panel finds 'no reason' to give toddlers over-the-counter cold meds

October 22, 2007     Spanish

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A U.S. Food and Drug Administration advisory panel says it finds no reason to give children under age six over-the-counter cold remedies.

The group sided with petitioners who are requesting a ban on these products for children younger than six.

The ban was requested by the City of Baltimore Health Department and has the support of many pediatricians, who have expressed concern the medicines can be dangerous – even lethal – if dosage instructions are not carefully followed. It’s up to the FDA to decide whether to accept its panel’s recommendations.

A number of pharmaceutical companies, including Novartis, Wyeth Labs, and Johnson & Johnson announced earlier this month that they were withdrawing infant over-the-counter cough medicine because of concerns of death and injury due to possible overdose.

Cold remedies – especially for children – have been under growing scrutiny in the last two years. Guidelines released by the American College of Chest Physicians in 2005 indicate that many of the "active" ingredients in cough remedies may be ineffective. The group says over the counter cough medicines should not be given to children under age 14.

The FDA began looking more closely at the issue of cough medicine for children earlier this year. In August, the agency said many cough remedies sold without a doctor’s prescription should not be given to young children with a physician's approval.

Earlier this month the FDA said it would take enforcement action against companies marketing cough and pain medications for children that contain hydrocodone. The agency says the narcotic has not been approved for treatment of coughs and colds in children, though it has been cleared for other, limited uses.

While over-the-counter remedies are a huge part of the pharmaceutical industry’s profits, health experts have been leery of them for some time. The Mayo Foundation for Medical Education and Research says most non-prescription decongestants and pain relievers may offer temporary relief of some symptoms, but can carry with them troublesome side effects.

“If used for more than a few days, they can actually make symptoms worse,” the group warns on its Website. “Keep in mind that acetaminophen (Tylenol, others) can cause serious liver damage or liver failure if taken in high doses. It's common for people to take Tylenol in addition to flu medications that also contain acetaminophen, which can lead to drug overdoses.”

The foundation recommends “old fashioned” cold treatments such as drinking plenty of liquids, gargling with warm salt water, using saline nasal sprays, increasing humidity, and eating plenty of chicken soup.

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