The Baltimore City Health Department and a group of pediatricians from children’s hospitals and pediatric departments in Maryland, along with pediatricians from Harvard and other institutions in Texas and Michigan, has petitioned the FDA to provide more warnings and information to consumers and doctors regarding the use of common cough and cold medications in children less than 6 years old.
They specifically ask the FDA to do three things:
- Advise the public that over-the-counter cough and cold medicines have not been shown to be safe or effective in children less than 6 years old.
- Advise manufacturers that the use of the term “infant” or “baby” or showing such pictures on boxes is not supported by scientific evidence and may be subject to FDA regulation at any time.
- Change the labeling on these medications to state that they have not been shown to be safe or effective in children less than 6 years old, and that they should not be used in children under 6 years old to treat colds or cough.
Warnings about the use of these medicines in children are not new; medical research and poison control centers have long reported problems with these medicines in children. The American Academy of Pediatrics and other professional organizations have warned about them for years. The CDC reported on infant deaths from decongestants and cough medicines a few months ago.
The FDA responded in a New York Times interview that they had already begun an investigation into the use of these drugs in children in mid-2006. The FDA has in recent years increased its investigation into nonprescription drugs, many of which are not approved or regulated as currently marketed. Several years ago it pulled the decongestant phenylpropanoloamine from the market due to strokes; recently, it required long-acting guaifenesin (an expectorant) to be approved and regulated by the FDA, removing all non-approved versions. Most recently, it pulled all non-approved medicines containing carbinoxamine, an antihistamine, from the market due to dangers from respiratory suppression. This drug was commonly used in infant and child prescription cold medicines.
