FDA Panel and Experts Call for Ban on Children’s OTC Cold Medicines
Related Pages:
- Concentrated Infants’ Tylenol Drops Plus Cold
- Concentrated Infants’ Tylenol Drops Plus Cold & Cough
- Dimetapp Decongestant Infant Drops
- Dimetapp Decongestant Plus Cough Infant Drops
- Infant Overdose from Cough and Cold Drug Toxicity
- Johnson & Johnson
- Little Colds Decongestant Plus Cough
- Little Colds Multi-Symptom Cold Formula
- Novartis Corporation
- Pediacare Infant Dropper Decongestant
- Pediacare Infant Dropper Long-Acting Cough
- Pediacare Infant Drops Decongestant
- Pediacare Infant Drops Decongestant & Cough
- Prestige Brands Holdings, Inc.
- Robitussin
- Triaminic
- Wyeth
On October 19, a United States Food and Drug Administration panel (FDA) voted to ban multisymptom over-the-counter cough and cold medicines for children under the age of six. The panel acts as an advisory to the FDA, and its decision does not necessarily mean product recalls will occur.
During a two-day meeting by the panel, FDA drug safety official Richard Abate told the panel OTC products could lead to accidental infant overdose from cough and cold drug toxicity due to the products containing multiple medicines.
The president of the Consumer Healthcare Products Association, Dr. Linda Suydam, told the panel that parents and caregivers commonly use the medicines as a sedative for children.
Dr. Robert S. Baum, a member of the panel and a pediatrician from the University of Chicago Medical Center, told the panel that pediatric cough and cold medicines are “a bewildering mess of complicated ingredients and combinations that do and don’t make sense.”
The panel voted 21 to one for the forced withdrawal of over-the-counter cold products for children under two. The vote to ban them for children under the age of six was 13 to nine.
In the United States there are an estimated 95 million units of children’s over-the-counter cold medicines sold each year. Notable medicines that would be affected if the FDA takes action are Johnson & Johnson’s Tylenol Plus Cold, Novartis AG’s Triaminic, and Wyeth’s Robitussin.
Sources: Gardiner Harris, “F.D.A. Panel Urges Ban on Medicine for Child Colds,” WSJ.Com, October 22, 2007; Gardiner Harris, “Ban Complex Drugs for Children, Official Says,” NYTimes.Com, October 22, 2007;Jenifer Corbett Dooren and Anna Wilde Mathews, “Cough-Medicine Dilemma Widens,” WSJ.Com, October 22, 2007.
