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The most common ailments plaguing infants and toddlers in the first few years of life are coughs and colds. A plethora of drugs are used to treat the same notwithstanding the fact that some cold medicines might be unnecessary. Concerned with the safety and effectiveness of some of the widely used cough and cold medicines, the U.S. Food and Drug Administration has announced it would be undertaking a review of these drugs come October.
The FDA is taking this measure to ensure cold medications meet desirable safety standards. The review follows many adverse reactions like injuries as well as deaths in some children aged below two years. According to the American Academy of Pediatrics, in the first two years of life alone, most children have eight to ten colds.
The best way to prevent these colds is to keep the infants and toddlers away from people suffering from colds themselves. "This is especially true during the winter, when many of the viruses that cause colds are circulating in larger numbers. A virus that causes a mild illness in an older child or an adult can cause a more serious one in an infant," the AAP warns.
However some parents are too anxious to see their tiny tots get well as soon as possible and may overdose their kids with cold medicines resulting in adverse reactions. It is these processes that the FDA is going to scrutinize thoroughly when its Nonprescription Drugs Advisory Committee meets this October.
Over-the-counter cough and cold medicines are also under the scanner because parents are liable to give too heavy a dose for these children.
"Over-the-counter treatments often dry the respiratory passages or make the nasal secretions even thicker. In addition, they tend to cause side effects such as drowsiness," the AAP said on its web site. "Never use cough medicines or cough/cold preparations in a child under three years of age unless prescribed by your pediatrician."
The U.S. Centers for Disease Control and Prevention's Morbidity and Mortality Weekly Report had warned about liberal use of cold medications in January this year.
The CDC said that it had identified three infants who died from the toxic effects of cough and cold medicines in 2005. In addition, in 2004 and 2005, over 1,500 children less than 2 years old were treated in U.S. emergency rooms for adverse events from cough and cold medicines.
The agency added that cold medications were effective in older children and adults; there were no studies to substantiate the effectiveness of the medicines in children aged less than two years.
"Parents should always consult a healthcare provider before giving cough or cold medicine to kids under 2 years old. Healthcare providers should use caution when giving cough and cold medicines to children under 2 years old," the CDC had warned.
Dr. Charles Ganley, the FDA's director of the Office of Nonprescription Products said the agency was looking into the safety of cold medicines since the middle of last year.
"We have not established a dose that is safe for children 2 and under," Ganley said. "We hope to have our review done in several months and then make recommendations."
He added that when the agency first approved cough and cold medications several decades ago, their safety was not taken into consideration at all. Furthermore these drugs were approved for use after being tested in adults or older children and were not specifically tested in infants.
This means the dosage of the drugs is a rough estimate and not accurate at all. One of the main ingredients causing concern is dextromethorphan, which is known to trigger abnormal movements and hallucinations even in low doses. Other ingredients like pseudoephedrine are known to cause infant deaths, increased blood pressure and arrhythmias, according to a report in The New York Times.
The FDA says that parents must take extra care when giving OTC drugs to their children. Following is the Public Health Advisory issued by the FDA:
What should parents know about using cough and cold products in children?
* Do not use cough and cold products in children under 2 years of age UNLESS given specific directions to do so by a healthcare provider.
* Do not give children medicine that is packaged and made for adults. Use only products marked for use in babies, infants or children (sometimes called “pediatric” use).
* Cough and cold medicines come in many different strengths. If you are unsure about the right product for your child, ask a healthcare provider.
* If other medicines (over-the-counter or prescription) are being given to a child, the child’s healthcare provider should review and approve their combined use.
* Read all of the information in the “Drug Facts” box on the package label so that you know the active ingredients and the warnings.
* Follow the directions in the “Drug Facts” box. Do not give a child medicine more often or in greater amounts than is stated on the package.
* Too much medicine may lead to serious and life-threatening side effects, particularly in children aged 2 years and younger.
* For liquid products, parents should use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with each different medicine formulation and that is marked to deliver the recommended dose. A kitchen teaspoon or tablespoon is not an appropriate measuring device for giving medicines to children.
* If a measuring device is not included with the product, parents should purchase one at the pharmacy. Make sure that the dropper, dosing cup or dosing spoon has markings on it that match the dosing that is in the directions in the “Drug Facts” box on the package label, or is recommended by the child’s health care provider.
* If you DO NOT UNDERSTAND the instructions on the product, or how to use the dosing device (dropper, dosing cup or dosing spoon), DO NOT USE the medicine. Consult your healthcare provider if you have questions or are confused.
* Cough and cold medicines only treat the symptoms of the common cold such as runny nose, congestion, fever, aches, and irritability. They do not cure the common cold. Children get better with time.
* If a child’s condition worsens or does not improve, stop using the product and immediately take the child to a health care provider for evaluation.
Most coughs and colds are caused by viruses and antibiotics do not work against them. In such cases parents are better off comforting their child and giving supportive care rather than cold medications, which might cause adverse reactions in children.
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