Cough And Cold Medicines Not For Children Under 6, Says Health Canada

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Main Category: Pediatrics / Children's Health
Also Included In: Respiratory / Asthma;  Pharmacy / Pharmacist;  Ear, Nose and Throat
Article Date: 22 Dec 2008 - 6:00 PST

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Manufacturers in Canada will have to relabel OTC (over-the-counter) cough and cold medicines that have pediatric dosing information to indicate that these medications should not be given to children under six years of age.

Health Canada says the products affected are those that contain any of the active ingredients listed below that are administered orally (via the mouth).

Active Ingredients Affected by Health Canada's Decision on Cough and Cold Products for Children

Antihistamines in cough and cold medicines
(used to treat sneezing, runny nose)

-- brompheniramine maleate
-- chlorpheniramine maleate
-- clemastine hydrogen fumerate
-- dexbrompheniramine maleate
-- diphenhydramine hydrochloride
-- diphenylpyraline hydrochloride
-- doxylamine succinate
-- pheniramine maleate
-- phenyltoloxamine citrate
-- promethazine hydrochloride
-- pyrilamine maleate
-- triprolidine hydrochloride

Antitussives
(used to treat cough)

-- dextromethorphan
-- dextromethorphan hydrobromide
-- diphenhydramine hydrochloride

Expectorants
(used to loosen mucus)

-- guaifenesin (glyceryl guaiacolate)

Decongestants
(used to treat congestion)

-- ephedrine hydrochloride/sulphate
-- phenylephrine hydrochloride/sulphate
-- pseudoephedrine hydrochloride/sulphate

According to Health Canada, the relabeling will be completed before the autumn of 2009, when the next cough and cold season starts. For the current cough and cold season medication will stay on the shelves of retail outlets and in homes with their existing labeling. This might include dosage information for children under 6, as many of them also have dosage information for children and adults on the same label. Consequently, for this cough and cold season, parent/caregivers are asked to consult a health care practitioner or pharmacist when purchasing or using these products. For children six and over, and for adults, these medicines can still be used.

Health Canada states in a press release that there is limited evidence supporting the effectiveness of cough and cold medicines in children. In addition, reports of overdose, misuse, and rare side-effects have raised concerns regarding the use of these medications in younger children. Rare but serious side-effects include increased heart rate, convulsions, decreased level of consciousness, abnormal heart rhythms and hallucinations. The Scientific Advisory Panel's conclusions and details of the new Health Canada recommendations can be seen on the Health Canada Web site.

Until the relabeling takes place, Health Canada recommends the following:

-- Do not give your child under six OTC medications for coughs and colds.

-- If your child is older than 6 make sure you follow all the instructions carefully - this includes the dosing and length-of-use directions, and the dosing device if one is included.

-- If a medication is labeled for adults do not give it to a child.

-- Do not give more than one kind of cough and cold medicine to a child. Cough and cold medications often contain multiple ingredients. Combining products with the same ingredient(s) could cause an overdose that may result in harm to a child.

-- Talk to your health care practitioner (doctor, pharmacist, nurse, etc.) if you have questions about the proper use of over-the counter cough and cold medicines.

-- The common cold is a viral infection for which there is no cure. Cough and cold medicines offer only temporary relief of symptoms such as runny nose, cough, or nasal congestion Symptoms can also be managed using a variety of non-medicinal measures such as adequate rest, increased fluid intake and a comfortable environment with adequate humidity.

-- For babies and young children, it is important to rule out serious illnesses that have cold-like signs and symptoms (for example, pneumonia, ear ache or other infections). This is especially important if symptoms do not improve, or if the child's condition worsens.

-- If you are concerned about the child's health (such as if symptoms worsen, last for more than a week, or are accompanied by a fever higher than 38 C or the production of thick phlegm), consult a health care practitioner for a medical evaluation.

Health Canada


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