FDA says cough and cold products used irresponsibly with children

Aug 20 2007

The Food and Drug Administration (FDA) in the United States says it is concerned that cough and cold products sold over the counter (OTC) are being irresponsibly used particularly with children under the age of two.

In order to ensure that cough and cold medications meet desirable safety standards, the FDA Nonprescription Drugs Advisory Committee will discuss the safety and effectiveness of cough and cold drug product use in children.

Worries regarding the safety of such products and whether the benefits justify any potential risks especially in children under two have prompted the meeting.

The FDA has apparently received reports of serious adverse events associated with the use of these products generally as a result of giving too much of the medicines to children.

The general public may not be aware that even an OTC cough and cold medicine can be harmful if more than the recommended amount is used, if it is given too often, or if more than one cough and cold medicine containing the same active ingredient are being used.

In order to avoid such events occuring the FDA says parents must carefully follow the directions for use of the product in the "Drug Facts" box on the package label.

The Public Health Advisory also offers parents and caregivers of children advice when using cough and cold products in children.

Most parents generally consider OTC products relatively harmless since they are freely available without a doctor's prescription.

But experts warn that many children are taken each year to hospitals for medical treatment after errors in dosing, accidental double dosing and two or more products being given at the same time containing the same active ingredients.

The CDC (Centers for Disease Control and Prevention) has revealed that in 2004 and 2005, more than 1,500 children were rushed to emergency departments with serious health problems after being given common remedies.

All were less than 2 years of age and three of the children died.

Other reports have suggested that young children up to the age of 6 may experience life-threatening adverse effects such as seizures, heart problems and hallucinations because of incorrect medication.

The FDA has issued a Public Health Advisory reminding parents of the dangers of overdosing a child with medicine pointing out that: -

• Children get over their coughs and calls automatically in time and the medicines actually treat the symptoms such as fever and runny noses rather than the cold itself.
• Parents must remember that overdosing a child, particularly one less than two years old, with too much of a medicine can cause serious life threatening side effects.
• Children under two should never be administered cough and cold medicines without a prescription from a doctor.
• Children should never be administered cough and cold drugs meant for adults.
• Cough and cold medicines are sold in different strengths and parents must always ensure that that particular medicine is of the right dose or strength for the child.
• A child's doctor should be told if the child is being given more than one drug so the doctor can review their combined use and monitor for overdosing and other dangers.
• Parents must read the drug fact section of the package and label carefully before administrating the medicine and always be on the alert for any adverse reactions and should consult the child's doctor if he or she is not clear about the dosage.
• A child should never be given more than the recommended dose no matter how serious the symptoms may appear and if no improvement occurs the doctor should be consulted again rather than overdose the child.
• In order to ensure that the child is receiving the correct dose it must be measured accurately with the correct device such as the accompanying dropper or measuring spoon and using a kitchen spoon should be avoided.

Experts also suggest that the amount of the drugs given to a child should be determined by the child's weight rather than his or her age, because children of the same age can have very different weight measurements.

Most doctors agree that such drugs should not be sold over OTC.