A number of non-prescription cough and cold medicines for children under two years old are being voluntarily pulled from the shelves, over fears that their improper use can lead to deadly overdose.
The Nonprescription Drug Manufacturers Association of Canada announced Thursday the voluntary withdrawal of oral cough and cold medicines intended for those under two years of age. The medicines being withdrawn include:
- Dimetapp Oral Infant Cold Drops (products with dye and without dye)
- Dimetapp Oral Infant Cold and Fever Drops
- Infants' Tylenol Cold Dye-Free Drops
- Benylin for Infants Cough and Cold Drops
- Benylin for Infants Stuffy Nose Oral Drops
As well, Shoppers Drug Mart says it will be withdrawing its Life Brand Oral Infant Cold Drops, Grape, 50 ml.
The NDMAC says the withdrawal is "a highly cautionary response to rare patterns of misuse identified during the course of a review of safety data related to children's cough and cold medicines."
"When used as directed, these products are recognized as safe and effective; however the identified misuse can result in excessive doses to children under the age of two," the industry group said in a news release.
In the U.S., the Consumer Healthcare Products Association, which represents U.S. makers of over-the-counter cough and cold medicines, also announced Thursday the voluntary withdrawals of some brands of oral cold medicines that refer to "infants."
In both countries, the withdrawal does not affect medications labeled for use in children age two and older.
The affected products in the U.S. are:
- Dimetapp� Decongestant Plus Cough Infant Drops
- Dimetapp� Decongestant Infant Drops
- Little Colds� Decongestant Plus Cough
- Little Colds� Multi-Symptom Cold Formula
- Robitussin� Infant Cough DM Drops
- Triaminic� Infant & Toddler Thin Strips� Decongestant
- Triaminic� Infant & Toddler Thin Strips� Decongestant Plus Cough
- TYLENOL� Concentrated Infants' Drops Plus Cold
- TYLENOL� Concentrated Infants' Drops Plus Cold & Cough
- PEDIACARE� Infant Drops Decongestant (containing pseudoephedrine)
- PEDIACARE� Infant Drops Decongestant & Cough (containing pseudoephedrine)
- PEDIACARE� Infant Dropper Decongestant (containing phenylephrine)
- PEDIACARE� Infant Dropper Long-Acting Cough
- PEDIACARE� Infant Dropper Decongestant & Cough (containing phenylephrine)
(The PEDIACARE brand is not available in Canada.)
The products were withdrawn after numerous reports of parents failing to follow the products' directions, resulting in overdoses and deaths,
In cases of overdoses, either too much medication was given, it was given too often, or more than one cough and cold medicine containing the same active ingredient were used.
"If you mistake a teaspoon for a tablespoon, if you give it five times a day instead of three times a day -- these are mistakes parents make," Dr. Michael Rieder of the Canadian Paediatric Society told CTV News.
FDA to review medications
The recalls come ahead of a decision by the U.S. Food and Drug Administration on whether sales of infant cold medications should be restricted or whether further warnings are warranted.
The agency announced in August that a panel of independent experts from its Nonprescription Drugs Advisory Committee would convene on Oct. 18-19 to discuss the matter.
The FDA launched the investigation after doctors petitioned the agency in March to review the situation and public health authorities raised concerns about the products.
That petition came on the heels of a Centers for Disease Control and Prevention report that found more than 1,500 toddlers and babies wound up in emergency rooms over a two-year period because of the drugs.
In September, the committee issued a preliminary recommendation that the "consult your physician" advice to parents on the labels of infant cough and cold medications be dropped, and parents advised instead to not give their young children cold and cough medicines at all.
The CHPA also backs the recommendation that cold and cough treatments not be used in children younger than two years old.
Health Canada says it is in the process of determining if the labelling of these products is sufficient "to ensure that parents, caregivers and prescribers have all the information needed to make an informed decision concerning the safe use of these products."
In addition, the agency strongly advises parents and caregivers to carefully read the labels and instructions for these products and to check the medicinal ingredients before giving them to any child, especially under the age of two.
The Canadian Paediatric Society advises that over-the-counter cough and cold medicines should not be given to children younger than three years old unless prescribed by their doctor.
"For cough and cold preparations, you first of all have to understand they're not going to cure anything," says Dr. Rieder. "While there's good evidence in adults that they make you feel better, the evidence in children under two is sparse and somewhat contradictory.
"If you're using them to make the child feel better, there's no evidence you get anything more from those products than just using a simple drug like ibuprofen or acetaminophen in the right dose, lots of fluids, a little bit of rest -- that gives you the same degree of symptomatic relief.
"There are specific reasons why children should use these products but those are best discussed with a physician. I really think these products should be only used under the age of two under the guidance of a physician."
