Volume 201 - Issue 7
New TGA warning label for use of NSAIDs in fluid-depleted children
Author: Ronald P Batagol
Med J Aust 2014; 201 (7): 381-382. || doi: 10.5694/mja14.00959
Published online: 6 October 2014
Published online: 6 October 2014
The recent TGA warning that NSAIDs can cause harm in fluid-depleted kids should also apply to adults at risk
To the Editor: Non-steroidal anti-inflammatory drugs (NSAIDs) have been very widely used for many years in Australia and elsewhere, in both prescription and non-prescription settings.
Although their potential for gastrointestinal side effects is generally well understood within the community, the capacity for NSAIDs to cause renal damage, even after short-term use in susceptible individuals, is less well appreciated.
It has been well documented that the use of NSAIDs in those who are fluid-depleted, including their short-term use in otherwise healthy individuals, can lead to renal failure, albeit reversible.1,2
On 23 May this year, the Therapeutic Goods Administration updated its Medicines Advisory Statements on labels for non-prescription medicines. Included was a warning about paediatric products containing NSAIDs.3 The wording of the advisory statement is “Ask your doctor or pharmacist before use of the medicine in children suffering from dehydration through diarrhoea and/or vomiting”.
As the person who initiated the request to have this warning label added, my intention was to have this warning added to all non-prescription NSAID-containing products for both adults and children, because we know that people who are renally compromised for any reason are at risk of kidney damage from the use of NSAIDs. This, of course, includes those taking some antihypertensive medications containing a diuretic, the well known “triple whammy” effect.4,5
Nevertheless, I hope that the warning label on paediatric products containing NSAIDs will alert parents and carers to be vigilant if giving these medicines to children in their care, and to check with their doctor or pharmacist if the child is fluid-depleted from diarrhoea or vomiting.
Competing interests
No relevant disclosures.
References
- John CM, Saroha V, Jones C. Using nonsteroidal anti-inflammatory drugs in volume-depleted children can precipitate acute renal failure. Pediatrics 2008; 121 Suppl 2: S142. _Ref398048752
- Moghal NE, Hegde S, Eastham KM. Ibuprofen and acute renal failure in a toddler. Arch Dis Child 2004; 89: 276-277. _Ref398048754
- Deparment of Health Therapeutic Goods Administration. Medicines Advisory Statements Specification 2014. F2014L00693. http://www.comlaw.gov.au/Details/F2014L00693 (accessed Aug 2014).
- Adverse Drug Reactions Advisory Committee. ACE inhibitor, diuretic and NSAID: a dangerous combination. Aust Adv Drug React Bull 2003; 22: 14-15. http://www.tga.gov.au/hp/aadrb-0308.htm#.U_Q8SKMUwxg (accesssed Aug 2014).
- Kidney Health Australia. Kidney Health Australia urges caution on “triple whammy” risks [media release]. 10 Oct 2006. _Ref398049231
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