Please login to the form below

Not currently logged in
Email:
Password:

FDA rules on children's cough medicines

The FDA has said that cough medicines should not be given to children aged under two years, unless approved by a doctor

The FDA has said that cough medicines should not be given to children aged under two years, unless approved by a doctor.

The ruling is the first major reassessment of the safety of children's cough and cold medicine for over ten years. Additional warnings about the drugs may materialise, because the FDA revealed it would be meeting with a panel of independent experts on 18 October.

It is anticipated that the experts will advise the agency about how new label warnings or prohibitions should be implemented. The panel will also discuss the ways in which parents and caregivers administer the drugs to children.

In high enough doses, cold medicines affect the beat of the heart and cause arrhythmia. Also, other types of cold and flu medicines constrict blood vessels. The medicines have been associated with high blood pressure, strokes and injury in cases where a child has been over-medicated.

The FDA has ruled that children should never be given cough and cold medicines which have been packaged for adults. The agency further advised that parents should closely follow label directions about the appropriate dose to give their children.

In March 2007, a group of paediatricians and public health officials petitioned the FDA to remove medicines intended for children under the age of six. The petition stated that the medicines did not work and could result in serious injury in rare cases.

The medicines under review include Toddler's Dimetapp, Infant Triaminic and Little Cold. Many of the active ingredients in these products have never undergone safety reviews by the FDA.

16th August 2007

Share

Featured jobs

Subscribe to our email news alerts

PMHub

Add my company
Cello Health

Cello Health’s mission is to help our clients unlock the potential that exists with their assets, brands and organisations in...

Latest intelligence

Beyond the event
...
Anthill Agency and Actando partnership to Transform Pharma's Digital Skills
Anthill Agency, a leading life sciences digital agency, today announced the launch of the Anthill Academy™ and partnership with Actando's PharmAcademy....
Is the pharma business model ready for precision medicine?
Precision medicine promises to revolutionise patient outcomes and reduce costs for industry but is pharma ready for it? Blue Latitude Health co-founder Head of Strategy Fred Bassett explores the challenges...

Infographics