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Cold Remedies Are Unproven For Children, FDA Panel Says
Group Advises Against Use In Kids Younger Than Age 6

By Rob Stein
Washington Post Staff Writer
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.

The FDA convened the hearing to evaluate doubts about the products' effectiveness and the mounting evidence that the medications can cause serious complications.

The companies maintain that the products are safe and effective when used properly but said they withdrew products for infants and toddlers because of the risk of complications when misused. Most complications occur in children younger than 2.

The companies support adding warnings to the labels of the dozens of products still on the market to caution parents that they should not be used for children younger than 2 or to sedate children, and promised to launch a nationwide campaign about how to use the products safely. They also said they would conduct additional studies.

"We're going to be working with the FDA, and we believe these products will stay on the market," said Linda Suydam, president of the Consumer Healthcare Products Association. "These products are safe and effective, and parents have depended on them for decades."

The hearing was prompted by a petition filed by a group of health officials led by Joshua M. Sharfstein, Baltimore's health commissioner, after the deaths of four children in that area.

"FDA and the companies should work quickly to end marketing of cough and cold products for children under age 6," Sharfstein said. "After hearing all the evidence, the advisory committee agreed that these young children should not be using these products. There is just no justification for formulations of these products geared at toddlers or depicting small children."

Many of the disputed products were approved decades ago when testing requirements were less stringent, and for decades parents have turned to them when struggling to help children suffering from one of the most common health problems -- colds, coughs and other respiratory illnesses. Although many leading medical groups have long recommended against their use, the products remain popular.

Many doctors say they advise parents against using the products and suggest they try other approaches, such as giving acetaminophen (Tylenol and other brands) to relieve pain, using humidifiers and saltwater solutions to alleviate congestion, and pushing fluids to keep the child hydrated.

But distressed parents can be persuaded by heavy marketing, critics said, noting that companies spend at least $50 million a year to promote the products. Americans buy about 95 million bottles of them a year, and there are more than 800 formulations in stores.

Some experts say studies show the medications are only marginally effective in relieving symptoms in adults as well, but there is no evidence that adults face as significant risks from the products.

The panel concluded that it was inappropriate to rely on studies conducted on adults to determine the effectiveness of the products for children, and called for new research to test the products directly in children.

"Children are not just small adults," said Jesse Joad of the University of California at Davis Medical Center.

The panel also voted that the dosages of liquid products and devices used to administer them be standardized to reduce the risk of overdoses, that all ingredients should be clearly listed on the labels, and that parents should be warned against using them to sedate children or using more than one product at a time. They also said terms such as "doctor recommended" should be eliminated from the packaging.

In addition, the panel voted to allow the continued marketing of products that contain multiple active ingredients and target more than one symptom, but it called for detailed studies about how well parents understand the instructions on using them safely.

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