FDA says OTC cough and cold medicines do not work for young children

Oct 22 2007

The Food and Drug Administration (FDA) in the U.S. are warning parents about the use of over-the-counter (OTC) cough and cold medicines in young children.

A panel of FDA experts say such products do not work and should not be given to children under 6 years of age.

According to FDA epidemiologist Sean Hennessy, from the University of Pennsylvania, the data indicates that medicines sold to treat common cold symptoms do not work.

The recommendation also applies to medicines containing one or more of the following ingredients: decongestants, antihistamines and antitussives; it does not however apply to expectorants, though many of the medicines also contain that ingredient.

The FDA's Office on New Drugs says if the agency chose to restrict use in children 6 and under, it will not necessarily lead to a ban on the products but might lead to labeling that advising 'do not use'.

Hennessy says though the FDA does not always follow the advice of external experts it does usually adhere to their recommendations.

The recommendation by the panel follows two separate votes where the panelists agreed that medicines be studied in children to determine if they really work.

The panel analysed the effectiveness and the risks of potential adverse effects caused by cold medicines and concluded that the drugs offer no beneficial effect on children, but do have potentially dangerous side-effects.

A few weeks ago some drug makers stopped marketing the medicines for children under 2 years of age, following reports of dangerous adverse effects.