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Cold Remedies Are Unproven For Children, FDA Panel Says
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.