Manufacturers of over-the-counter (OTC) pediatric cough and cold medicines are advising parents not to give them to children under four years of age.
“Leading makers of these medications are voluntarily transitioning the labeling on oral over the counter pediatric cough and cold medications to state “do not use in children four years of age and under,” said a statement issued Tuesday by the Consumer Healthcare Products Association.
“We think this was the right thing to do for the parents,” said Linda Suydam, president of the Consumer Healthcare Products Association.
By instructing parents not to give these medications to children under 4, the new label sends the message that these medications are "safe and effective" for children 4 and over. This assertion is not true, said Public Citizen in a press release.
A recent published study demonstrated that OTC cough and cold medications have not been proven to be effective in children under 12.
Medications baring new warning labels will begin appearing in pharmacies and stores immediately, although, experts are still debating at what age they may be safe and effective.
The new labeling also advises against using antihistamines to sedate young children.
In January, the FDA issued a public health advisory warning about over-the-counter (OTC) cold and cough medicines for babies and toddlers under the age of two.
Each year 7,000 children under the age of 11 are taken to the hospital due to adverse reactions from cough and cold medications, most commonly the result of accidental overdoses. Adverse reactions include hives, difficulty breathing and dizziness.
The Centers for Disease Control and Prevention reports that from 2004-2005, 1,519 children under two were treated in emergency rooms from an overdose of the cold medications. Overdosing can occur when parents give two different products with the same active ingredients or give too much of a dose too frequently.
Last year, an FDA advisory panel voted to remove all over-the-counter pediatric cough and cold products for children younger than 6 years of age.
“I am disheartened that the FDA has not complied with the recommendations made by its own advisory panel,” Sen. Christopher J. Dodd (D-Conn.) said. “Another cold and flu season is nearly upon us, yet, commonly available products are still being marketed to parents of small children despite experts raising serious questions regarding their safety effectiveness.”
At an FDA hearing on October 2, consumer and medical groups clashed over the issue of over the counter cough and cold medications for children, with some groups calling on the agency to pull them off of shelves and make them available by prescription only.
That could affect as many as 800 cough and cold medications in the U.S. market.
The agency is collecting more scientific research before they make a decision, said Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research.
In the meantime, parents can visit OTC Safety for information and resources about safe dosages and using over-the-counter medications. #
* Editors Note: Do you think there should be age restrictions on cough and cold medications for children? Two, six or even twelve years of age? Has your child ever suffered an adverse affect from one of these medications? Share your opinion or experience with us below in the comment section.