Over-the-Counter Cough and Cold Medicine Unsafe for Children Under TwoAug 20, 2007 | Parker Waichman LLP, LLP
The Food & Drug Administration (FDA) will meet in October to discuss the use of cough and cold medicines in young children, but until then, the agency is warning that such over-the-counter medications should rarely, if ever, be given to children under two years of age.
Earlier this year, a study by the Centers for Disease Control (CDC) found that 1500 children nationwide had been treated in emergency rooms for problems related to over-the-counter cold medicines. That same report also found that 3 babies had died as a result of misused cold medications. The CDC findings caused the FDA to launch an investigation into the use of these drugs in children.
Last week, the FDA issued a health advisory on the use of over-the-counter cold and cough medicines in young children. Many of these dangerous drugs are decades old, and as a result, they have never been tested in clinical trials. Some experts believe that this oversight has resulted in injury to many small children over the years. Many of these medications include ingredients like dextromethorphan, a drug in the codeine family. Too much dextromethorphan can have a sedative effect in babies. Another drug commonly found in over-the-counter medications, pseudoephedrine, has a stimulant effect, and can actually lead to strokes and hypertension if too much is given to a baby.
As a result of its investigation, the FDA issued guidelines regarding the use of cold and cough medications in small children. First and foremost, caregivers should read all of the information in the "Drug Facts" box on the package label and follow directions carefully. These medicines should not be used in children under 2 years old unless a doctor specifically says they should. Caregivers should not give medicine to a child more often or in greater amounts than is stated on the package. Too much medicine may lead to serious and life-threatening side effects. Children should never be given medicine that is packaged and made for adults. Caregivers should seek the advice of a health care provider when choosing a brand of medicine for a child. Health care providers should be informed about any other medicines that a child is taking so that the physicians can check on possible drug interactions. And caregivers are urged to use the measuring device (dropper, dosing cup or dosing spoon) that is packaged with the medicine. A kitchen teaspoon is not an appropriate measuring device for giving medicines to children.
The FDA will hold a meeting of the Nonprescription Drugs Advisory Committee on October 18 and 19, 2007 to discuss the continued use of these cold preparations in young children.