Baby Cold Medicines Removed: Fears Grow About Dosage, Effectiveness for Tots

By Bruce Japsen, Chicago Tribune

Oct. 12—- The latest and most serious warning about over-the-counter cough and cold medicines came Thursday when productmakers said they would withdraw their remedies from the market for children younger than 2, fearing dosages were not being given appropriately.

The withdrawal, voluntarily made by some of the biggest makers of cough and cold remedies, affects only “infant” oral medicines, often labeled as “infant drops.” The market is large, running in the millions of units sold each year by such pharmaceutical giants as Novartis AG, Johnson & Johnson and Wyeth, as well by large retailers like CVS/Caremark Corp., which said it would remove equivalent products under its own brands.

The highly unusual move by the industry comes in the wake of skepticism that has been building over the last decade, and escalating for much of the last year, about the safety of cough and cold medicines for children under 6. At the same time, doctors increasingly are doubtful about whether the products are effective and therefore worth risks that include heartbeat irregularities and death.

“Their effects are dubious and, with a potential for harm, I caution parents against giving them,” said Dr. Ken Lyons, a Chicago pediatrician at Children’s Memorial Hospital. “Why take the chance? There are so many different brands that they cause confusion and there is minimal benefit at best with a potentially bad side effect.”

More than 800 over-the-counter cough and cold products are sold in the U.S., with about 95 million units a year sold for infants and children, according to documents submitted to the Food and Drug Administration by the industry in preparation for a meeting of agency advisers next week to discuss the use of cough and cold remedies for children under 6.

A panel of experts is expected to offer recommendations to the FDA on whether over-the-counter cough and cold remedies are safe. The experts likely will provide more guidance to parents of children over 2.

Depending on what the FDA panel says, its advice could unsettle a U.S. market for all cold and cough products estimated at more than $3.7 billion and growing, including more than $311 million in children’s cold remedies, according to Nielsen Co.

Doctors say problems tend to occur when parents give a child one brand that ends up not working and then try something else. A combination or high dosage in a short amount of time can cause health risks.

“It’s probably a safe move to remove them [from shelves] because it will eliminate confusion,” Lyons said. “It’s been seen through and through with kids and adults, quite frankly, that these don’t really work well.”

The medicines are marketed under brand names such as Dimetapp Decongestant Plus Cough Infant Drops and Little Colds Decongestant Plus Cough.

Doctor groups, including the Elk Grove Village-based American Academy of Pediatrics, have voiced concern about the risks of cold and cough medicines for at least a decade. In 1997, for example, the academy warned about overdose potential and other risks with certain cough suppressants.

In January, the U.S. Centers for Disease Control and Prevention published a study of hospital emergency departments that found more than 1,500 children younger than 2 were treated for “adverse events, including overdoses, associated with cough and cold medications.” The report identified three deaths. The CDC study cited cough and cold medicines that contain nasal decongestants, antihistamines and cough suppressants, among other remedies.

In August, the FDA issued a health advisory that the public “not use cough and cold products in children under 2 years of age unless given specific directions to do so by a health-care provider.”

Pediatricians say that often the best medicine for a cough or cold is to wait it out, telling patients that a viral illness needs to run its course. Doctors say parents are drawn to medications because of marketing and the desire to provide relief.

“At the end of the day, these medicines are putting a finger on the whole dam,” Lyons said.

Because it often can feel unsettling for parents to sit back and watch as their child suffers, doctors urge parents to remain calm and reassuring.

“It’s just going to get worse for the child if the parent is upset,” said Dr. Daniel Fratterelli, a Detroit emergency pediatrician and pharmacologist who is on the American Academy of Pediatrics committee on drugs. “That kind of nurturing and patience does more good than perhaps anything else.”

The industry stands by the products’ safety as long as they are used according to their labels, describing problems as rare.

“It’s important to point out that these medicines are safe and effective when used as directed, and most parents are using them appropriately,” said Linda Suydam, president of the Consumer Healthcare Products Association.

“The reason the makers of over-the-counter, oral cough and cold medicines for infants are voluntarily withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants, and safety is our top priority,” she said.

Some pediatricians believe the products should be dosed by weight and age and encourage parents to consult with doctors for small children.

– — –

Baby sick? What to do:

Amid safety concerns and questions about effectiveness, the medical community has moved away from recommending cough and cold medicine for children younger than 2. The FDA advises parents avoid these medicines unless given specific directions to do so by a health-care provider.

Instead of giving medicine, pediatricians suggest parents:

–Let the cold run its course.

–Run a humidifier to help moisten the throat and nasal passages to provide relief.

–Help the baby find a comfortable sleeping position, whether in a seated position or in a car seat.

–Comfort the child; it’s a surprisingly easy remedy.

bjapsen@tribune.com

—–

To see more of the Chicago Tribune, or to subscribe to the newspaper, go to http://www.chicagotribune.com.

Copyright (c) 2007, Chicago Tribune

Distributed by McClatchy-Tribune Information Services.

For reprints, email tmsreprints@permissionsgroup.com, call 800-374-7985 or 847-635-6550, send a fax to 847-635-6968, or write to The Permissions Group Inc., 1247 Milwaukee Ave., Suite 303, Glenview, IL 60025, USA.

NYSE:NVS, NYSE:JNJ, NYSE:WYE, NYSE:CVS,