In view of concerns raised on the recent recall in the United States of over-the-counter cough and cold products marketed for infants and toddlers, and the ensuing recommendations from the public advisory committee meeting convened by the US Food & Drug Administration (FDA) on the safe use of these medicines in young children, HSA has provided an interim advisory to healthcare professionals on the appropriate use of these products while we continue to review the scientific data. These recommendations were included in the Dear Healthcare Professional Letter issued on 30 October 2007 and posted at the MOH Health Professional portal at
http://www.hpp.moh.gov.sg.
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Table 1: Interim recommendations on use of cough and cold medicines in various age groups of children
Category | Under 6 months | 6 months to 2 years | 2 years and above |
| Promethazine | Contraindicated | Not recommended | Use with caution |
Antihistamines (Brompheniramine, chlorpheniramine, diphenhydramine)* | Not recommended | Use only when benefits have been assessed to outweigh risks. | Use with caution |
| Cough suppressants (Codeine, dextromethorphan, diphenhydramine)* | Not recommended | Use only when benefits have been assessed to outweigh risks. | Use with caution |
| Cold and flu products (Pseudoephedrine, ephedrine, guaifenesin, phenylephrine)* | Not recommended | Use only when benefits have been assessed to outweigh risks. | Use with caution |
* Active ingredients discussed during the meeting between US FDA and its expert panel for which adverse event reports were analysed.
Background
The recent recall in the US in October 2007 involved 14 brands of cough and cold preparations (containing antihistamines and decongestants) targeted for infants and very young children. They were voluntarily recalled by drug companies due to the danger of overdosage and misuse in this group of patients. Examples of such products are Concentrated Infants' Tylenol Drops Plus Cold & Cough, Dimetapp Decongestant Plus Cough Infant Drops, and Decongestant Infant Drops. HSA confirms that these products are not licensed for sale or use in Singapore.
The US FDA has also convened an expert advisory committee in October to deliberate on the efficacy and safety of cough and cold products being used in children under six years of age. In view of the lack of efficacy data in young children balanced against the occurrences of rare but serious adverse drug reactions (ADRs) associated with the use of these products, the expert panel recommended stronger cautionary labels on these products and not to use of these products in children under six years old. FDA will deliberate on the panel's recommendations before coming to a conclusion on this issue.
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Review of data by US FDA
A review of the adverse reports from the US FDA associated with the antihistamines (diphenhydramine, brompheniramine and chlorpheniramine), and the decongestants (pseudoephedrine, phenylephrine, and ephedrine) over 1969–2006 revealed that most of the ADRs occurred in children under two years old and overdosage and drug toxicities were the common causes. A further analysis of the adverse event reports associated with pseudoephedrine, chlorpheniramine, diphenhydramine and dextromethorphan from 2002–2007 showed that serious events and deaths related to the nervous system (e.g. seizures), cardiac and respiratory system were associated with both overdoses as well as labelled doses of cough and cold medicines. There is also a potential risk of overdose when using multiple cough and cold products.
Local situation
HSA has not received any local reports of fatal adverse drug reactions associated with cough and cold medicines. However, taking into consideration the findings by US FDA and the lack of efficacy data of cough and cold medicines used in children, HSA has provided the local healthcare professionals with an interim advisory on the use of cough and cold medicines in young children. This advisory takes into account the previous review conducted by HSA and its Pharmacovigilance Advisory Committee in 2005 on the use of promethazine in children under two years of age.
