Cold Medicine Is Not for Infants
FDA Advises Caution for Over-the-Counter Medications in Children
An FDA Public Health Advisory was released Jan. 17 warning against using over-the-counter cold medications in children under 2 and to exhibit caution under the age of 11.
In October of last year, an FDA panel warned against the use of over-the-counter cold and cough medications for children under the age of 6 due to ineffectiveness. A voluntary market recall of medicines labeled for use in infants was 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. On January 17, just three months after the panel’s recommendations, the FDA released a Public Health Advisory concerning the use of such medications in children under the age of 2. A review of the safety of over-the-counter cold medications in children between the ages of 2 and 11 is ongoing.
The Problems With Cold Medications And Children
It is reported that 7,000 children under the age of 11 visit the emergency room each year suffering from problems caused by over-the-counter cold medications. Many cases are due to accidental or unsupervised ingestion. The greatest fear is an overdose, particularly of acetaminophen or narcotics used in the medications to treat cold symptoms such as coughing and nasal congestion. Previously it was believed that doubling up on over the counter and prescription medications or giving a younger child a medication dosed for older children were the problems.
However the latest advisory indicates that all over-the- counter cold medications, regardless of how they are marketed, are unsafe for infants and toddlers. The FDA advisory cites that “serious and potentially life-threatening side effects can occur” if young children and infants are given cold medications. The voluntary recall in October removed the medications from store shelves and this advisory insures they will not be returning.
What To Do for Children between Ages 2 And 11
The FDA has yet to complete its review of the safety of over-the-counter cold medications in children between the ages of 2 and 11. In the recent advisory, the agency recommends that any parents or caregivers who must give cold medication to their child be very careful to not give multiple medications, especially if they contain the same active ingredient. They also recommend to:
- Check the labels and drug fact sheet that accompanies the medication. Read the purpose of the ingredients and do not double up on antihistamines especially.
- Follow the directions and dosage precisely, using the measuring spoon or cup that comes with the medication.
- Purchase bottles with child proof caps and store out of the reach of children.
- Understand that cold medications treat the symptoms. A child will be sick for just as long either with or without the medication.
- Not use cold medications as a sedative or to help a child sleep.
- Contact a physician with questions or concerns.
Recommendations for treating the cold in children include some old-fashioned advice - plenty of fluids, chicken soup, gargling with salt water, and nasal sprays.
