FDA panel urges ban

A federal drug advisory panel concluded yesterday that over-the-counter cough and cold remedies should not be given to children under 6 because of safety concerns, and found no evidence that the remedies are even effective in children under 12.

The panel recommended that the Food and Drug Administration prohibit drug makers from marketing the formulations to children under 6 and require that they change the wording on labels from "Consult a Physician" to "Do Not Use."


They said the phrase "Pediatrician Recommended" and similar wording should be removed from packaging, and recommended that the industry conduct trials to determine whether the remedies are actively effective in children, and in what doses.

The medications include products that millions of parents have given their children for decades - marketed under familiar brand names such as Dimetapp, Robitussin and Tylenol.


The ruling was bad news for industry officials, who say the 95 million packages of children's cold remedies they sell every year generate $311 million in revenue.

The advisory panel's nonbinding but influential vote came eight months after a pediatricians group led by Dr. Joshua M. Sharfstein, Baltimore's health commissioner, petitioned the FDA to stop the sale of cough and cold medicines for young children.

The petition created a national uproar, and even before the two-day hearings began, the industry voluntarily pulled 14 infant cold and cough remedies from store shelves.

"This is a definite victory for the health of children," Sharfstein said yesterday.

"And I think it will promote the more rational care of children who are sick. It's important now for the industry and the Food and Drug Administration to make sure these products are not marketed to children under 6."

Even if the FDA agrees with the panel's findings, officials said it could take years to change the way the drugs are treated under federal regulations.

Still, drug industry officials were unhappy.

"We disagree with the advisory committee's recommendations in some places. ... We think we presented data that really showed that these products are safe and effective," said Linda Suydam, the president of the Consumer Healthcare Products Association, which represents most of the manufacturers.


She said the companies will conduct new studies on the drugs' efficacy but have no plans to pull products for children 2 and older from store shelves. The medications covered by the panel's recommendations are decongestants, cough suppressants, antihistamines and combination products that contain more than one of those ingredients.

The FDA panel did not address the use of some drugs - mostly antihistamines - to treat allergic reactions.

FDA officials cautioned that the agency has not made any decision on the panel's recommendations. "We have to take all of this information back and discuss it thoroughly within senior people in the agency to decide what we might want to say about today's meeting," said Dr. John Jenkins, director of the Office of New Drugs in the FDA's Center for Drug Evaluation and Research.

"Our general advice remains to be cautious and aware of over-the-counter medications when you're using them," he said. "Follow the directions carefully. Make sure you check to be certain you're not using multiple products that have the same active ingredient, that might lead to an overdose."

He emphasized that the FDA does not recommend the medications for use in children under 2 and advised parents to ask a doctor or pharmacist if they're unsure whether or how much to give a child.

Even if drug companies act aggressively, it will take two to three years to conduct convincing studies to determine whether the drugs are effective in children.


Since many of the drugs were approved during the 1970s and no one has argued that their continued use represents a national emergency, officials said it could also take the FDA years to determine whether to allow their continued marketing for children under 6.

Meanwhile, Jenkins said, the agency will consider making an official recommendation to parents, but he declined to say when.

The FDA is not bound by the advisory panels' opinions, but such recommendations typically carry weight in the agency's decision-making.

The panel made additional suggestions. For example, it voted to ask the companies to conduct studies on how children of different ages and sizes respond to the medication.

Because parents sometimes overdose youngsters by using a cup or spoon from one medicine with a different drug, the panel recommended that drug makers include standardized dosing devices such as cups, spoons and syringes with bottles of cough syrup and other liquids.

The panel experts concluded that the few small studies conducted among children showed no evidence that the medications are effective for treating cough and cold for children under 12.


They said it was no longer proper to extrapolate clinical trial results from adults and apply them to children - a common practice in the 1970s, when most of the drugs were originally approved.

Thus they recommended specific studies involving children.

"Suppos'n is good, findin' out is better," said Dr. Dennis Bier, a Texas pediatrician, quoting Mark Twain in summing up the expert panel's opinion. "I don't see that there is any reason to extrapolate data."

The experts on the panel disagreed over whether the products for children between the ages of 6 and 12 should be removed from the market.

Amy J. Celento-Stamateris, a New Jersey mother representing patients on the panel, was worried about unintended consequences.

"My concern is that by taking these medications off the market, parents are going to have limited options," she said. "I do not administer these products to my child, but there are many, many parents who will use adult formulations for children."


The panel voted 13-9 that the drugs should not be given to children under 6 but split 15-7 against the same warning for children ages 6 to 11.

Sharfstein said his petition was prompted by increasing evidence that children are being harmed by the drugs, including four deaths in Baltimore over a six-year period.

Industry representative argued that the drugs were indeed safe and effective, that the vast majority of problems reported were minor, and that most serious reactions were the result of overdoses by adults who did not read the label instructions.

Still, the companies said they would voluntarily conduct the type of children's studies the panel recommended and launch a campaign to teach parents and doctors how to avoid giving children the wrong medications or the wrong doses.

For children under 2, they also agreed to change dosage recommendations from "Ask a doctor" to "Do not use."



Over-the-counter cough and cold remedies should not be given to children under 6.

No evidence exists that the medicines are effective in children under 12.

Studies on adults don't answer the question of whether the drugs work in children. Separate clinical trials involving youngsters should be conducted.

Statements such as "Doctor Recommended" should be removed from product labels