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Kids Cough Medicine Gets Warning Labels; Critics Not Impressed

"Will do little to protect children," Public Citizen charges

October 8, 2008

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Bowing perfunctorily to pressure from physicians and consumer organizations, makers of over-the-counter cough and cold medicine say they are changing their labeling to advise parents not to give their products to children under age four.

"The manufacturers are once again attempting to delay more definitive action by the Food and Drug Administration (FDA)," said Peter Lurie, M.D., MPH, Deputy Director of the Health Research Group at Public Citizen. "The FDA must use its authority to make a strong, evidence-based decision not to allow these medications to be available to children under 12, rather than let the industry engage in this type of self-serving self-regulation."

Physicians' groups say the medicine does little good, and may be harmful to young children.

The FDA has agreed with the doctors that there is little or no data to support the medicines' benefits but nevertheless stopped short of ordering pediatric cough and cold medicines from the market. The voluntary move was announced by the Consumer Healthcare Products Association, an industry-supported group which maintains that children's over-the-counter cough and cold medicines are safe and effective when used as directed.

"Research shows that dosing errors and accidental ingestions -- not the safety of the ingredients themselves when properly dosed -- are the leading causes of rare adverse events in young children," said Linda Suydam, president of the group.

But Lurie said the action "clearly represents a political compromise, not a solution based on scientific evidence. It will do little to protect all children from these ineffective and, therefore, needlessly dangerous products."

The new labels on oral OTC pediatric cough and cold medicines will state "do not use" in children under four years of age; the modified labels will continue to provide dosing information for children four and older.

In addition, for products containing certain antihistamines, manufacturers said they are voluntarily adding new language that warns parents not to use antihistamine products to sedate or make a child sleepy. Adult cough and cold medicines are not impacted by the label update.

Advice for parents

"I do not give my kids over-the-counter cough medicine," said Thomas Fahey, professor of general practice at the Royal College of Surgeons in Ireland Medical School. "I do not advise my patients to do so."

Fahey led a recent study of over-the-counter cough medicines that concluded the products don't do very much, even for adults. He said people often worry about a cough if it has not gone away after a week. Actually, the duration of a cough is commonly two weeks in children and three weeks in adults.

"I think there's the laymen's perception," Fahey said. The common conclusion is that "something should be done about it. It [coughing] is troublesome at night. But it is not a bad thing to be coughing. It could be helpful. It is a mechanism for shedding viruses."

How effective?

Public Citizen's Lurie questioned the effectiveness of the new labels.

He noted that a little over a year after manufacturers of over-the-counter (OTC) cough and cold medications agreed to voluntarily withdraw their products for children under 2 from the market, a small Public Citizen survey found that less than a quarter of cough and cold medications on sale in two major pharmacies in Washington, D.C., and Baltimore, Md., carried labels warning parents not to use these medications in children 2 or younger.

"We have no confidence that today’s proposed 'voluntary' measures by members of the CHPA (which does not represent all manufacturers of OTC cough and cold medicines, particularly generic ones) will be any more effective," he said.

And, Lurie charged that, by announcing a 4-year-old age restriction -- halfway between the current voluntary limit of 2 years of age and the age limit of 6 requested in a petition submitted last year -- the manufacturers are "once again attempting to delay more definitive action by the Food and Drug Administration (FDA)."

"By instructing parents not to give these medications to children under 4, the new label sends the message that these medications are 'safe and effective' for children 4 and over. This assertion is not true," he said, noting that reviews by FDA Medical Officers and a more recent published study demonstrate that OTC cough and cold medications have not been proven to be effective in children under 12.

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