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FDA Warns of Cough, Cold Medicine Risk to Children

Warning doesn't go far enough, Public Citizen charges

By Mark Huffman
ConsumerAffairs.com

January 18, 2008

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This just in – the U.S. Food and Drug Administration has issued an advisory on cough and cold products for children, three months after the drug manufacturers themselves warned the products might be harmful to children under age two.

In a Public Health Advisory for parents and caregivers, the agency recommends that over-the-counter cough and cold products should not be used to treat infants and children less than 2 years of age because serious and potentially life-threatening side effects can occur.

Most U.S. pharmacies began to remove those products after the drug company's warning, issued on October 12, 2007. However, the recall was voluntary and not all of the products were immediately removed.

The consumer organization Public Citizen said the FDA's warning is not only late but inadequate.

"By simply warning parents not to administer over-the-counter cough and cold remedies to children under the age of two, the FDA has failed to properly address the glaring risks presented by this category of drugs," Public Citizen said.

In fact, the group said, there is no evidence that these products are safe and effective for children over the age of two the group said. The agency didn’t even follow the recommendation of its own advisory committee, which voted on Oct. 19 to limit these products to children over the age of 6, Public Citizen charged.

Drugmakers have long claimed that pediatric cough and cold preparations, made popular through heavy marketing of a dizzying variety of combination products in child-friendly flavors, provide relief for cough and cold symptoms but Public Citizen said the products have never been proven to be effective.

Ineffective, unsafe

“The advisory committee declared the products were ineffective in younger children, but we were not able to identify a single adequately designed study that compared the efficacy of these products in older and younger children,” Dr. Peter Lurie, deputy director of Public Citizen’s Health Research Group. “Thus the product’s efficacy remains unproven in all children under the age of 12.

“The companies have known for decades that their products are unproven, yet they have continued to foist them on concerned parents who believe that the FDA protects them and their children from ineffective medications,” said Lurie.

“Simply because these drugs are well-tolerated by many children is not an adequate rationale for allowing them on the market. The law is clear that ineffective medications are not to be sold, no matter how safe they appear to be,” he said.

Adverse effects

This week's FDA advisory stated that there are a wide variety of rare, serious adverse events reported with cough and cold products. They include death, convulsions, rapid heart rates, and decreased levels of consciousness.

"The FDA strongly recommends to parents and caregivers that OTC cough and cold medicines not be used for children younger than 2," said Charles Ganley, M.D., director of the FDA's Office of Nonprescription Products. "These medicines, which treat symptoms and not the underlying condition, have not been shown to be safe or effective in children under 2."

The announcement does not include the FDA's "final" recommendation about use of OTC cough and cold medicines in children ages 2 to 11 years. The agency's review of data for 2-to-11-year-olds is continuing, according to the FDA. The agency said it would issue its recommendations on use of the products in children ages 2 to 11 years as soon as the review is complete.

The FDA said that pending completion of the FDA's ongoing review, parents and caregivers that choose to use OTC cough and cold medicines to children ages 2 to 11 years should:

• Follow the dosing directions on the label of any OTC medication,

• Understand that these drugs will NOT cure or shorten the duration of the common cold,

• Check the "Drug Facts" label to learn what active ingredients are in the products because many OTC cough and cold products contain multiple active ingredients, and

• Only use measuring spoons or cups that come with the medicine or those made specially for measuring drugs.

The FDA recommends that anyone with questions contact a physician, pharmacist or other health care professional to discuss how to treat a child with a cough or cold.

October recall

In October, Wyeth Pharmaceutical recalled some children’s cough medicine because the bottle caps, used to measure dosage, don’t accurately mark the half-teaspoon level recommended for children ages 2 to 5.

The recall affected several Robitussin products and Children’s Dimetapp Cold & Chest Congestion.

While the company said there was nothing wrong with the medicine, dosage can be critically important when administered to young children. Public health officials, including the City of Baltimore Health Department, recently asked the Food and Drug Administration to ban cough medicines for kids because overdosing can cause serious injury and even death.

A taste of honey

A natural solution to the problem may be at hand.

A study published in December found that a single dose of buckwheat honey before bedtime provided the greatest relief from cough and sleep difficulty compared with no treatment and an over-the-counter cough medicine in children with upper respiratory tract infections.

The study was published in the December issue of Archives of Pediatrics & Adolescent Medicine.

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