Manufacturers Remove Drugs for Infant Cold

1. Manufacturers Remove Drugs for Infant Cold By GARDINER HARRIS Published: October 12, 2007 http://www.nytimes.com/2007/10/12/us/12cold.html?adxnnl=1&adxnnlx=1192216228-Tg9wsOxwq9NFWBGk8/jaJQ

2. Product Withdrawal Recommended 2 Weeks Earlier • WASHINGTON, Oct. 11 — Major makers of over-the-counter infant cough and cold medicines announced Thursday that they were withdrawing their products from the market for fear that they could be misused. • The voluntary withdrawal, already under way, affects only products labeled for use in infants, not for use in children 2 and older. And some small companies could continue selling infant products. More changes, perhaps mandated by federal drug regulators, could be in the offing. • The withdrawal comes two weeks after safety reviewers within the Food and Drug Administration urged the agency to consider an outright ban of over-the-counter cough and cold products for children under 6. Even the industry’s main trade group, the Consumer Healthcare Products Association, recommended two weeks ago that the products not be used in infants.

3. Industry Admits Some Patterns of Misuse • Despite the recommendation, giant drug makers like Johnson & Johnson, Wyeth and Novartis continued to sell cough and cold products labeled for infants. Last week, Representative Henry A. Waxman, the California Democrat who is chairman of the House Committee on Oversight and Government Reform, sent a letter to the industry’s trade association asking why the products were still being sold. • Until Thursday, industry representatives answered that they were discussing the issue with the F.D.A. and defended their medicines as safe and effective. • “The reason the makers of over-the-counter oral cough and cold medicine for infants are withdrawing these medicines is that there have been rare patterns of misuse leading to overdose recently identified, particularly in infants,” said Linda A. Suydam, president of the trade association. • “Safety is our top priority,” Ms. Suydam added.

4. What We Know • Next week, a committee of outside experts will consider the safety of these medicines and offer recommendations to the agency. Dianne Murphy, director of the agency’s office of pediatric therapeutics, said in an interview that in addition to asking basic questions about the drugs’ safety and effectiveness, the agency intended to question the experts closely about the advisability of combination medicines. It will also explore how to address accurate dosing when there are a dizzying array of measuring devices, some provided by the manufacturers and some not. • The experts will also consider whether children from 2 to 6 should be given these medicines. “I don’t recommend their use in any child,” said Dr. Daniel Frattarelli, a pediatrician from Detroit who serves on the American Academy of Pediatrics’ committee on drugs. “These medicines don’t help, they may hurt, so don’t use them.” • There are 800 over-the-counter pediatric cough and cold products. In the fiscal year that ended July 15, makers sold at least 41 million units of these products in the United States, about a fifth in the form of drops that are generally given to infants, according to the trade association. A 1994 study found that more than a third of all 3-year-olds in the country were given over-the-counter cough and cold preparations in one 30-day span.

5. Evidence of Efficacy • There is little evidence that cough and cold medicines are effective in young children, and there are increasing fears that they may be dangerous. From 1969 to 2006, at least 45 children died in the United States after taking decongestants, and 69 died after taking antihistamines, according to the F.D.A. • Many children were sickened after they were mistakenly given too much — either because parents failed to realize that products from two makers contained identical medicines or because parents had given improper amounts. But there are reports that even children given recommended doses are at risk. • Infant cough-and-cold products were approved decades ago without adequate testing in children because experts assumed that children were simply small adults, and that drugs approved for adults must also work in children. More recent research showed that neither assumption was true. Indeed, recent studies suggest that pediatric cough and cold medicines work no better than placebos.

6. The Economics MC ' $ MB MC • We have MB; we have MC. • There are arguably both, but are they perceived accurately? MB' • Are MB << than we thought? • Are MC >> than we thought? U*opt U* Usage