November 22, 2007 — Vol. 43, No. 15
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Debate over cold meds for kids hinges on safety issue

Liz Hoffman

The first frost of the season hit Boston last week, and as every parent knows, the colds, coughs, stuffy noses and sore throats aren’t far behind.

But when parents go to the medicine aisle this winter, they may find fewer options, the result of a new set of federal recommendations handed down late last month.

An advisory committee appointed by the Food and Drug Administration (FDA) voted to ban many pediatric cough and cold medicines amid growing concerns that the medications are generally ineffective and potentially unsafe, particularly for small children.

The committee voted 21-1 on Oct. 19 to ban the use of these drugs — which include staples like Dimetapp and Robitussin, as well as several products in the Tylenol line — in children under 2, who have suffered the majority of serious adverse effects over the past several decades. Side effects are rare, but with more studies supporting skeptics’ claims that the drugs do not actually alleviate cold symptoms, many physicians and professional organizations consider them an unnecessary risk.

“The guiding principle here should be that if a drug is ineffective, then its risk, unless zero, will always exceed its benefits,” said Dr. Michael Shannon, chief of emergency medicine at Children’s Hospital Boston and one of four pediatricians who addressed the advisory panel prior to its vote. “These drugs do not work.”

The American Academy of Pediatrics and the American College of Chest Physicians have come out in support of the ban.

These drugs, now among the biggest over-the-counter sellers on the market, were approved as “generally regarded as safe” and placed on what is known in the industry as the GRAS list. Many hit shelves as early as the 1960s and have faced little scrutiny in the decades since; before last month, the FDA had conducted no review of their safety or effectiveness since 1976. Most of these drugs were not tested explicitly on children and dosing recommendations for children were extrapolated from adult dosages based on weight.

“You can’t simply adjust the dose for child weight and assume that it is safe or that the effect will be the same,” Shannon said. “Knowing what we know about pediatric pharmacology … the GRAS list needs to be reexamined. Cough and cold preparations are just the most high-profile offenders.”

Adverse outcomes are rare, but serious. An FDA internal review in February 2007 found that from 1969 through 2006, 123 deaths were attributed to the active ingredients in most cough and cold medicines — 54 to decongestants and 69 to antihistamines. The majority of these occurred in children under 2. A report by the Centers for Disease Control and Prevention found that in 2004 and 2005, more than 1,500 children under the age of 2 experienced serious effects from cough and cold drugs.

Some of these cases are the result of accidental overdoses. Acetaminophen, the active ingredient in Tylenol products, can cause liver failure in high doses, as can some antihistamines.

To address that danger, many drug manufacturers have announced plans to standardize the measuring caps across the industry to prevent unintentional overdoses that occur when parents use a cap from one medicine to measure another.

But many of the more serious cases are the result of dangerous drug interactions rather than overdose, Shannon said. Children with epilepsy, heart problems, or liver and kidney diseases are particularly susceptible to many of the ingredients in these drugs.

“The agents in cough and cold preparations can be very potent,” he said. “There’s a very long list for medications ... that could interact with these drugs and parents don’t always know.”

How the panel’s recommendation will impact parents’ choices is unclear. The vote was much closer, 13-9, for children aged 2 to 6, and failed, 15-7, for children aged 6 to 12. The FDA is not required to follow the recommendations of its advisory committees, and according to Shannon, history has shown that the closer the vote, the less likely it is to sway the agency.

“The FDA will be the main factor in predicting what actually happens to pharmacy shelves,” Shannon said. “If they ban it, they ban it, and if they don’t, the industry has some tough decisions to make.”

Those decisions include weighing potential legal liability and a swarm of bad press against the estimated $2 billion that Americans spend each year on children’s cold medicines.

Many of the companies, including industry giants like Wyeth and Johnson & Johnson, have discontinued the drops and dissolvable strips that they market specifically for infants.

Wyeth issued a voluntary withdrawal of its Children’s Dimetapp Cold and Chest Congestion and several of its Robitussin products late last month and will re-label its drugs to include “do not use” warnings for children under 2.

“The safety of our consumers is our top priority, and we believe it’s important to work with FDA to determine the most appropriate course of action to ensure that cough and cold medicines for children be used safely by parents,” Wyeth spokesman Doug Petkus said.

As the industry and the FDA draw a new line in over-the-counter cold care, parents will face new challenges in dealing with a familiar problem. Shannon said that it’s best to remember that colds, while uncomfortable, are not serious, and in the absence of fever, should be allowed to run their course.

“A cold is a brief illness with few to no consequences and there really aren’t a lot of things that work to relieve cough or congestion anyway,” he said. “That’s not something that parents necessarily want to hear, but it’s true.”

Dr. Michael Shannon, chief of emergency medicine at Children’s Hospital Boston, addressed an FDA-appointed committee that voted to ban many pediatric cough and cold medicines for young children. (Banner file photo)

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