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Infant Cold Medicine Recall

Ineffective Medications And How To Treat A Child Without Them

Oct 22, 2007 Alicia Mae Prater

An FDA panel has found cold and cough medications to be ineffective in children. For kids, treating colds the old-fashioned way is best.

A voluntary market recall of medicines labeled for use in infants was recently announced by The Consumer Healthcare Products Association, a trade group representing Wyeth, Novartis, and Johnson & Johnson, the manufacturers of popular over the counter cold and cough medications Dimetapp, Robitussin, Pediacare, and Triaminic. This preceeded an FDA panel’s recommendation that over-the-counter medicines should not be used with children under the age of 6 due to ineffectiveness. The medications have never been tested in children, though the components themselves have been deemed safe, but no dosing standards were approved for children by the FDA. As of now the recall involves only medications for children under the age of 2, though The American College of Chest Physicians decided in 2005 that most active ingredients are no more effective than placebo and recommend not using the medications in children under the age of 14.

Specific Ingredients To Avoid in Children's Cold Medication

Steps are being taken to address concerns about safety. Hydrocodone is a narcotic used in some cough remedies that has not been approved for the treatment of cold and cough in children. The FDA stated on Oct. 1 that they will take legal action against any companies marketing such medications for use in children. In June of 2006 the FDA took enforcement action to stop the manufacture of carbinoxamine-containing medications that had not been approved by the agency. Many of the medications were inappropriately labeled for use in infants and young children. Though manufacturers were required to cease production, some products might still be in distribution. Even earlier, in 1997, the American Academy of Pediatrics issued a policy statement advising education for parents regarding the ineffectiveness and risk of using medications containing codeine and dextromethorphan in young children.

The federal Combat Methamphetamine Epidemic Act of 2006 banned over the counter sales of pseudoephedrine-containing medications, but permits behind-the-counter sales in limited amounts. Because of this act, pseudoephedrine has been removed as an ingredient in many cough and cold medications and replaced with other nasal decongestants. There are alternatives to using these medications. Nasal congestion in infants can be cleared with a rubber suction bulb; secretions can be softened with saline nose drops or a cool-mist humidifier.

The Risks of Using Cold Medicine in Children

Despite the fears about using cough and cold medications in children, the Centers for Disease Control (CDC) and the National Association of Medical Examiners (NAME) found that only an estimated 1,519 children under the age of 2 were treated in U.S. emergency departments for adverse effects or overdoses associated with cough and cold medications during 2004-2005. Also, there were only three investigated deaths of infants under the age of 6 months associated with cough and cold medication use. The infants were found to have elevated levels, nine to 14 times the recommended dosage, of pseudoephedrine in their blood or to have been given multiple medications.

How to Treat a Cold

It could take years to reclassify cold and cough medications and begin testing to determine efficacy and dosing in children. While many remain on the market for children over 2 years of age, it is not necessary to use them. The Mayo Foundation for Medical Education and Research’s recommendations for treatment of cold and cough are to drink plenty of fluids, gargle with warm salt water, use saline nasal sprays, increase humidity, and to eat plenty of chicken soup. If a medication is needed, first consult a physician. Be sure to tell him/her if over-the-counter medications are being used, do not double up on medications, avoid increasing acetaminophen dosages, and follow the physician’s directions precisely.

The copyright of the article Infant Cold Medicine Recall in General Medicine is owned by Alicia Mae Prater. Permission to republish Infant Cold Medicine Recall in print or online must be granted by the author in writing.

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