Cold Remedies Are Unproven For Children, FDA Panel Says
Saturday, October 20, 2007
Over-the-counter cough and cold medications should not be used in children younger than age 6, a special panel of federal advisers concluded yesterday after an exhaustive review of the products' safety and effectiveness.
The Food and Drug Administration panel voted 13 to 9 to recommend against the use of the products for children in that age group after concluding overwhelmingly that there was insufficient evidence 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 to 7 to reject a call to discontinue use of the products for children 6 to 11 years old, 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 clear 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 many parents and pediatricians 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 votes against use by children younger than 6 and, earlier, 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. Americans spend more than $300 million a year on such products, marketed under well-known brands such as Robitussin, Dimetapp and Tylenol.
The committee's recommendations also apply to antihistamines used to treat allergies, although the focus of the review was on their use in cough and cold medications.
The FDA is not bound by the committee's conclusions, but the agency usually follows the advice of its advisory panels. FDA officials said they would review the complex recommendations and decide how to proceed. Because the products have been on the market so long, formal action could take years, officials said. But the agency plans to consult with the industry about possible voluntary action and whether to offer the public interim advice.
"We need to go back and review all these recommendations," the FDA's John Jenkins said. "The message from the panel is that they haven't seen adequately controlled studies that these products work in children."
No one knows how many children have had adverse reactions to the medications, but the federal Centers for Disease Control and Prevention reported earlier this year that at least 1,500 children younger than 2 suffered complications in 2004 and 2005. An FDA review prepared for the meeting described dozens of cases of convulsions, heart problems, trouble breathing, neurological complications and other reactions, including at least 123 deaths.
The hearing came a week after major manufacturers of the medications voluntarily withdrew 14 products designed for children younger than 2, including well-known brands such as Dimetapp Decongestant Plus Cough Infant Drops, Tylenol Concentrated Infants' Drops Plus Cold and Robitussin Infant Cough DM Drops.