FDA warns against cold and cough remedies made for children

Oct 2 2007

Safety experts in the United States are warning parents about buying over-the-counter cold and cough remedies, specifically marketed for children.

The Food and Drug Administration (FDA) says not only are such products ineffective they are also unsafe and should not be given to children.

Cough and cold 'cures' with fruit flavors specifically aimed at children are widely available in drugstores across the country.

But a new report by experts at the FDA suggests these medicines may not always be safe and for young children in particular are not worth the risks.

The FDA report recommends no level of dosage for children under the age of two, "due to the lack of evidence of efficacy and safety concerns."

The Consumers Healthcare Products Association says the real problem is "misuse" and "overdose" and says labels on most boxes which suggest that parents "consult with a doctor" about the appropriate dosage for children under the age of 2, only serve to add more confusion.

The FDA also says the warning is "confusing," and appears to contribute to "medication errors, which can result in fatal overdoses."

The review found 54 reported deaths from decongestants over the past four decades, most in children under the age of 2.

The FDA has announced it will act to stop the marketing of unapproved prescription drug products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs.

Hydrocodone is one of the strongest medications available to treat pain or to suppress cough.

It has also been an extremely popular drug of abuse and can lead to serious illness, injury, or death, if improperly used.

Hydrocodone overdose can result in breathing problems or cardiac arrest, and its use may impair motor skills and judgment.

The FDA says it is particularly concerned about the use of hydrocodone cough suppressants in children which is unapproved and improper labeling increases the risk of error regarding doses.

Though some hydrocodone pain-relief products, such as Vicodin, are FDA-approved, most of the hydrocodone formulations now marketed to suppress coughs have not been approved.

Dr. Steven K. Galson the director of the FDA's Center for Drug Evaluation and Research (CDER) says no hydrocodone cough suppressant has been established as safe and effective for children under 6 years of age and some of these unapproved products carry labels with dosing instructions for children as young as 2 years of age.

The CDER says there are products on the market with inadequate safety information on their labeling improperly suggesting that the products may be used safely by very young children.

There are seven FDA-approved cough suppressant products on the market containing hydrocodone and also are a variety of approved antitussive products that do not contain hydrocodone.

The FDA says anyone marketing unapproved hydrocodone products that are currently labeled for use in children younger than 6 years of age must end further manufacturing and distribution of the products on or before October 31, 2007.

Those marketing any other unapproved hydrocodone drug products must stop manufacturing such products on or before December 31, 2007 and must cease further shipment in interstate commerce on or before March 31, 2008.

The FDA says legal action will be taken against those failing to meet these deadlines.