Washington: Over-the-counter cough and cold medications should not be given to children younger than age 6, a panel of federal advisers concluded after an exhaustive review of the products' safety and effectiveness.
The Food and Drug Administration (FDA) panel voted 13-9 to recommend against the use of the products for children in that age group after concluding overwhelmingly there was insufficient evidence that the long-used remedies worked in youngsters. "The sentiment here is that they should not be used," said Mary E. Tinetti of Yale University School of Medicine, who chaired the group.
The panel, however, decided against making a similar recommendation for older children. It voted 15-7 to reject a call to discontinue use of the products for children ages 6 to 11, even though it had earlier agreed there was no evidence that the products do any good for that group, either. The votes reflected a division within the committee. While there was consensus that the effectiveness of the products had not been demonstrated and there was serious concern about their safety for the youngest children, particularly those younger than 2, several members said parents and paediatricians nevertheless depend on the remedies.
"Parents are using these medications to relieve what they consider symptoms, which in reality means their child is sedated and they are able to sleep," said committee member Amy J. Celento-Stamateris, who represented parents. "My concern is that by taking these products off the market parents would have limited alternatives."
The vote against use by children younger than 6, and an earlier vote that the products should be banned for those younger than 2, are likely to have a significant impact on dozens of products that have been mainstays for millions of parents.
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