US FDA Panel: Cough Medicine Ban for Children Under 6
In a move that could impact on how parents tend to their children when ill, the US Food and Drug Administration’s advisory panel recommended on the 19th October that over-the-counter cough/cold medicines should not be taken by children below six years. The majority vote solidified the call that the likes of antihistamines, decongestants and antitussives should be avoided in children aged between two and six, based on the absence of medical trial results, and these medicines’ benefits being outweighed by their risks.
The vote followed by mere days the decision taken by a number of high-profile pharmaceutical firms to remove certain products from the market.
The risk element of children’s cough/cold medicines emanates from instances when they have been administered at either too high a dose, or combined with similar treatments. According to doctors, a tendency in parents is to provide their children with a particular brand, then divert to another one when the first seems to be ineffective.
Mirroring the results of previous research, and the advice of doctors, the FDA panel referred to cardiovascular complications and even death in respect of the risk elements. "The [panel] expressed concerns about the lack of studies that showed positive benefits these products have in children", said the US FDA’s Office of New Drugs director, Dr John Jenkins.
Now, the US FDA will deliberate over the recommendation given by its panel. Should it be put into place, however, the impact on the cold medicine industry stateside could be immensely devastating.
The panel’s recommendations are usually subsequently adopted by the agency, although such adherence is not mandatory. According to one official, the chance is that children’s cough/cold medicines designed for sub-six year olds will not be banned, but their labelling could be modified to make the situation clear.
Pharmaceutical International will continue to provide unrivalled coverage of the very latest developments to emerge in the future of child decongestants et al in the US as we get the facts.
Source – Pharmaceutical International’s US Correspondent
Drug Firms Withdraw Children's Cold Medicines
