Medical experts and consumer groups requested the Food and Drug Administration to pull children's cough products and cold medicines off the market or make them obtainable only by means of a prescription.
A hearing was held yesterday by the FDA to ask for opinions regarding the changing of the rules. While reaching a conclusion may take a long time, the results could involve a tougher regulatory environment for a great number of cough products and over-the-counter cold. For instance, drug manufacturers may be asked to seek the agency’s approval for their products by complying with requirements similar to those for prescription drugs.
A year ago, the agency strongly advised customers not to administer cold medicines to children up to age 2, due to presumptive side-effects that could put their lives in jeopardy. Currently, federal health officials are thinking of limiting sales of such products intended for children under the age of 6.
"Parents should know that there is less evidence than ever to support the use of over-the-counter cough and cold medicines for young children," asserted Joshua Sharfstein, MD, Commissioner of Health in Baltimore City, Maryland.
According to FDA’s estimates, about 800 cough products and cold medications are put up for sale in the United States. Approximately 95 million packages of children's over-the-counter cold and cough medicines are bought annually, said the market research company Information Resources. Every year, American families spend more than $286 million on cough and cold remedies for their toddlers, according to The Nielsen Company, another market research firm.
© 2007 - 2009 - eFluxMedia