ASMI advice on soluble OTC medicines containing sodium

28 November 2013

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28 November 2013 - The results of a new UK study that suggests a number of effervescent or soluble medicines containing sodium may cause health problems if taken on a long-term basis1 should be interpreted with caution, the Australian Self Medication Industry (ASMI) said today.

As a large population-based study, ASMI believes the study offers some useful insights into potential issues relating to high sodium content in some of these medicines. However, as a case control study, the study does not prove cause and effect, therefore there is no solid evidence that sodium in these medicines causes cardiovascular disease.
While the study data were adjusted for recorded smoking and alcohol intake, data on unmeasured or unmeasurable risk factors such as health behaviour and family history were not available, and the researchers had no data on dietary sodium and could not control for this.

Some effervescent formulations of analgesics containing paracetamol, paracetamol plus codeine, and aspirin as well as some effervescent vitamin and mineral products are marketed in Australia. However, not all of the formulations included in the UK study are available in Australia.

ASMI Executive Director Dr Deon Schoombie emphasised that OTC analgesics are not indicated for long term use, which appears to be where the problem of excessive sodium may arise. In addition, use according to label directions should not pose a risk to cardiovascular health.

"Infrequent, short-term use of non-prescription effervescent or soluble medicines containing sodium has not been found to be associated with increased risk of cardiovascular events.

"Nevertheless, the new study provides a timely reminder to consumers, particularly those who use OTC effervescent or soluble analgesics, to only take these products for a few days at a time, as directed, and to talk to a healthcare professional if symptoms persist," Dr Schoombie said.

In Australia, the Therapeutic Goods Order for labelling and packaging (TGO 69) requires a declaration of sodium content on all non-prescription medicine labelling when the sodium content exceeds 120 mg per day. High sodium intake from medicines is most likely to occur when frequent doses are taken - for example, two effervescent tablets four times a day.

As with any medicine, consumers should seek advice from their healthcare professional on appropriate use of medicines. In particular, people with pre-existing cardiovascular conditions or hypertension should talk to their doctor or pharmacist and should check the sodium content of their medicines.

For more information or to arrange a media interview, please contact:
Michelle Sollitt-Davis
PR Manager, Australian Self Medication Industry (ASMI)
T: 02 9923 9410 M:0422 084 951 E:

About ASMI: The Australian Self-Medication Industry (ASMI) is the peak industry body for the Australian self care industry representing consumer healthcare products including over-the-counter medicines and complementary medicines. ASMI'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 Australians at a reasonable cost. ASMI 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.

1. Jacob George, Waseem Majeed, Isla S Mackenzie, Thomas M MacDonald, Li Wei. Association between cardiovascular events and sodium-containing effervescent, dispersible, and soluble drugs: nested case-control study. BMJ 2013;347:f6954 doi