Trend Watch



Tuesday, May 6, 2008


Health Canada and the U.S. Food and Drug Administration (USFDA) have raised concerns over the safety of cough and cold medicines (which are sold over-the-counter in these countries), especially in children below 2 years of age, and whether the benefits justify any potential risks from the use of such products.
In August 2007, US federal health advisors also recommended to the USFDA that such medicines do not work and should not be used by children aged below 6. Such cough and cold products typically contain one or more of the following ingredients: decongestants, antihistamines and anti-tussives. Although cough and cold medicines may also contain expectorants, current concerns do not apply to this ingredient.
Recently, the USFDA issued a Public Health Advisory for parents and caregivers, recommending that Over-the-Counter(OTC) cough and cold products should not be used to treat infant and children less than 2 years of age because serious and potentially life threatening side effectd can occur from such use. The adverse events reported with these products include death, convulsions, rapid heart rates and decreased levels of consciousness. However, USFDA are still evaluating the safety of these products in older children.

Both regulatory authorities are in the midst of determining if the labeling of these cough and cold products is sufficient to ensure that parents, caregivers and prescribers have enough information to make an informed decision regarding the safe use of these products.

In Malaysia, cough and cold products such as decongestants, antihistamines, and anti-tussive are classified as Group C Poison.

In May 2006, the Drug Control Authority (DCA) instructed that all products containing promethazine should not be used in children less than 2 years old due to reports of serious adverse events in this group of children and a warning statement to that effect was included for such products. The DCA is currently undertaking a review of scientific data and evidence on the use of cough and cold products in children and is also monitoring the regulatory moves of other agencies on this matter.

The DCA recommends all healthcare professionals to use cough and cold products containing decongestants, antihistamines and anti-tussives as a single ingredient or in combination when benefits have been assessed to outweigh the risks. The following recommendations need to be considered when prescribing or dispensing these products to patients:

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  • Not recommended in children less than 2 years of age because of serious and potentially life threatening side effects.

  • Children of all ages:

    • If it is necessary to give a cough and cold product to a child, make sure all labels and instructions are read before doing so. If the product does not contain dosing information for children then it should not be used in children.

    • Do not give a child a larger dose or more frequently than it is recommended in the labeling and instructions.

    • Take note of the medicinal ingredients in the product especially if more than than one product may be given to a child. Be aware that many products contain the same medicinal ingredient(s) and combined use could lead to overdose. Some herbs used in cough and cold products and some over-the-counter products used to control fever may also have medicinal ingredients similar to those in other cough and cold products.

    • It is advised not to give more than one cough and cold products to a child as cough and cold products often contain multiple ingredients.

    • There is no cure for the common cold. Children will usually recover from coughs and colds in time on their own. The common cold is a mild,viral infection that can be managed by rest, sufficient fluid intake and comfort measures.

    • In young children and babies, it is sometimes important to rule out serious illnesses (for e.g. pneumonia or other infections) which may present with cold-like symptoms; this is especially important if symptoms persist or if the child's condition deteriorates.


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