Several big drug-makers are voluntarily recalling some of their cough and cold products for under-two-year-olds in the US as a precautionary measure against overdosing on the drugs.
Novartis, Wyeth and Johnson & Johnson are three of the companies taking certain cough and cold medicines off shelves following a recent assessment of data by US officials which suggested "rare instances of misuse" of the products in children under the age of two.
The data was presented to the US Food and Drug Administration (FDA) last month after officials said earlier in the year they would be reviewing the products. The reports were found to "suggest that the use of prescription and over-the-counter cough and cold medication in younger children, particularly in children less than two years of age, could result in fatal overdoses".
According to documents, the FDA has received 123 reports of deaths between 1969 and 2006 that are related to the use of antihistamines and decongestants, with most deaths being in children two years and younger.
The product recall comes a week before officials are to meet to discuss safety recommendations for the products.
Following the review of the data, it was recommended that the drug labels carry stronger language advising parents the medicine should not be used for children under the age of two to prevent incidents of misuse.
This recommendation and others will be discussed by a panel of outside experts on October 18 and 19.
As yet the FDA has not taken a stance on the issue, preferring to wait instead to be advised by the panel. However, two months ago the agency did issue an advisory warning that cough and cold medicines should not be given to children under two years of age without direction from a doctor.
Fourteen cough and cold medications are affected by the recall including: Concentrated Infants' Tylenol Drops Plus Cold; Pediacare Infant Drops Decongestant; and Robitussin Infant Cough DM Drops; Dimetapp Decongestant Plus Cough Infant Drops; Little Colds Multi-Symptom Cold Formula; and Triaminic Infant & Toddler Thin Strips Decongestant.
Many contain acetaminophen, phenylephrine or pseudoephedrine.
The recall does not affect infant and children's pain relievers, single ingredient analgesics and nasal spray, drops or rubs for infants, or cough and cold medicines for children aged two and above.
A spokesman from the Consumer Healthcare Products Association was unavailable for comment at time of publishing.
Meanwhile, last month, the FDA announced its intention to take enforcement action against companies marketing unapproved products containing hydrocodone, a narcotic widely used to treat pain and suppress coughs but which is a very popular drug of abuse.
The agency is particularly concerned about improper paediatric labelling of unapproved hydrocodone cough suppressants and the risk of medication error involving the unapproved products.
FDA approved hydrocodone formulations would not be affected.