Makers Pull Infant Cold Medicines
WASHINGTON, Oct. 11 — Major makers of over-the-counter infant cough and cold medicines announced today that they were voluntarily withdrawing their products from the market for fear that they could be misused by parents.
The voluntary withdrawal affects only products labeled for “infants,” not those for use in children 2 and older. And some small companies may continue selling the products.
The move 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 the age of 6. Even the industry’s own trade association, the Consumer Healthcare Products Association, recommended two weeks ago that the products should no longer be used for infants.
Despite this recommendation, makers 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 “in direct contradiction to this recommendation, however, many C.H.P.A. member companies are currently marketing these products for use in children under 2.”
Next week, a committee of outside experts will meet to consider the safety of these medicines and offer recommendations to the agency.
There are roughly 800 over-the-counter pediatric cough and cold products. In the year prior to July 15, makers sold at least 41 million units of these in the United States, according to the healthcare products group, about a fifth of which were sold in the form of “drops” that are generally targeted for use in infants.
The industry said that the medicines are safe and effective when used as directed.
“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, and safety is our top priority,” said Linda A. Suydam, president of the trade association.
There is very 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 after taking decongestants, and 69 died after taking antihistamines, the industry association has said.
Many of these children were injured after their parents mistakenly gave them too much, either because they did not realize that products from two different makers contained identical medicine, or the parents measured doses poorly. But there are growing reports that even children given recommended quantities of the medicines are at risk.
The Poison Control Center of the Children’s Hospital of Philadelphia recently reported on four cases of prolonged hallucinations in children as old as 6 who were given recommended doses of the medicines.
With almost no evidence that they are effective and growing worries that they may be unsafe, a group of prominent pediatricians petitioned the agency earlier this year to consider banning the drugs’ use in young children.
Among the products being withdrawn are Dimetapp Decongestant Infant Drops, Little Colds Decongestant Plus Cough, Pediacare Infant Drops Decongestant, Robitussin Infant Cough DM Drops, Triaminic Infant and Toddler Thin Strips Decongestant, and Tylenol Concentrated Infant Drops Plus Cold and Cough.
Dimetapp and Robitussin are products of Wyeth; Little Colds is made by the Medtech Products unit of Prestige Brands Holdings; Tylenol and Pediacare are made by the McNeil Consumer Healthcare unit of Johnson & Johnson; and Triaminic is made by Novartis.
None of the companies’ stocks moved significantly today; by midafternoon Novartis and Johnson & Johnson were trading slightly higher, and Wyeth and Prestige Brands slightly lower.