Response to Consumer NZ review on cold & flu medicines

May 4, 2017

Consumers can use OTC cough and cold medicines with confidence

Consumer healthcare products industry body, the New Zealand Self-Medication Industry (SMI), says consumers can continue to use over-the-counter (OTC) cough and cold medicines with confidence.

SMI strongly disagrees with Consumer NZ’s latest article on over-the-counter cough and cold remedies and its assertion that evidence for the effectiveness of these products needs further review by authorities.

OTC cough and cold medicines are registered with the Government’s regulating body, Medsafe. Medsafe evaluates and holds all the evidence required on safety and efficacy of all ingredients.

“Consumers may, therefore, be assured that registration by Medsafe means that the available evidence has been clinically assessed as acceptable for safety, quality and efficacy under the Medicines Act,” comments SMI executive director Scott Milne.

Mr Milne says that although many of the ingredients in OTC cough and cold medicines were developed a long time ago and some efficacy data may, therefore, not be recent, that is no reason to conclude such products do not work.

“There is some recent efficacy data on dextromethorphan hydrobromide. The Therapeutic Goods Administration (TGA) Australia monograph or clinical paper on this ingredient that we sent to Consumer NZ was only published 18 months ago.[1]

“Most of the ingredients mentioned in the Consumer NZ article have been available in cough and cold preparations for more than 30 years. OTC cough and cold products have a long history of safe use in New Zealand in both adults and children.”

Individual OTC medicines suppliers are also responsible for the claims they make about their products and must follow the NZSMI Code of Conduct and Medsafe regulations.

SMI was approached last month by Consumer NZ for information relating to the efficacy of some ingredients in cough and cold medicines.

“We provided a number of relevant studies and references supporting their effectiveness to the journalist,[2]” comments Mr Milne.

He says that in 1976, the US Food and Drug Administration (FDA) released a monograph or clinical paper on OTC cough and cold products. This reported that phenylephrine(PE) is an effective nasal decongestant on the basis of in-house studies on phenylephrine(PE) provided by representatives of pharmaceutical companies.

On the basis of these in-house studies, the FDA approved phenylephrine(PE) as an effective nasal decongestant. In a further review in 1994, the FDA upheld this decision.

Another ingredient mentioned in the Consumer NZ article, dextromethorphan, was approved in the 1950’s for the effective treatment of cough.

Limited new studies have been conducted on these ingredients because they are well understood actives, approved for use in cough and cold medicines globally.

In conclusion, the regulatory authorities in Australia and NZ and indeed, globally, have concluded that phenylephrine and dextromethorphan are effective for the symptomatic relief of decongestion and cough respectively.

Moreover, clinical trials as suggested by the Cochrane Collaboration, are not the only evidence of efficacy.

“Not surprisingly, companies have not sought to spend time and money to run further clinical trials on an already-approved drug.

“OTC cough and cold medicines have a safe and effective profile and New Zealanders can use them with confidence if they want to,” Mr Milne concludes.

-ENDS-

About SMI: The New Zealand Self-Medication Industry Association Inc (SMI) is the national trade association representing manufacturers, marketers and distributors of a wide range of products, generally available "over-the-counter" (OTC) and mainly for use in self-medication by New Zealand consumers. Membership totals 44 companies of which 12 are the country’s largest drug manufacturers, importers and distributors; the balance is made up of smaller OTC manufacturers and distributors and Complimentary Health Care companies.

SMI’s mission is to promote better health through responsible self-care. This means ensuring that safe and effective self-care products are readily available to all New Zealanders at a reasonable cost. SMI works to encourage responsible use by consumers and an increasing role for cost-effective self-medication products as part of the broad national health strategy.

https://www.tga.gov.au/otc-medicine-monograph-dextromethorphan-hydrobromide

https://www.ncbi.nlm.nih.gov/pubmed/17692721

Dicpinigaitis et al “Antitussive Drugs – Past, Present, and Future” Pharmacol Rev 66:468-512, April 2014.

‘Guidance Document: Non-prescription Oral Adult Nasal Decongestant Labelling Standard’ (http://www.hc-sc.gc.ca/dhp-mps/prodpharma/applic-demande/guide-ld/label-etiquet-pharm/decon-eng.php )

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