OTC ibuprofen pain medications no danger to testosterone production when used as directed

10 January 2018

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The Australian Self Medication Industry (ASMI) said today that people who follow the on-pack instructions for over-the-counter (OTC) ibuprofen products should not be concerned by reports on research associating prolonged use of ibuprofen and the risk of a disruption to testosterone production.

This follows the release of a Franco-Danish study published this week in the journal of the National Academy of Sciences of the USA, which investigated the link between prolonged use of ibuprofen in a small group (14 participants) of young, healthy men and a disruption in the regulation of testosterone production.

Doctors in Copenhagen who led the study said that this disruption was mild and temporary in the volunteers.

It should be emphasised that the dosage and duration of the ibuprofen intake in the study is not representative of typical use of over-the-counter ibuprofen products, and it far exceeds the recommended duration of use. Study participants took 1200mg of ibuprofen a day (the equivalent of 6 x 200mg pills or capsules - the indicated maximum daily dose for OTC products in Australia) for six weeks. OTC ibuprofen products in Australia are indicated a few days use at a time only, and consumers are recommended to see their doctor if pain persists after this time.

The study made no conclusion suggesting that similar effects would take place at more commonly used lower doses and use over a few days.

The Therapeutic Goods Administration's own rigorous review of OTC NSAIDs (a class of medicines that includes ibuprofen), concluded that: "These drugs provide effective pain relief when used according to the label at recommended doses for short durations," 1 and; "The use of OTC NSAIDs was safe when they were used according to the recommended doses for short durations, as instructed on the label."2

ASMI Regulatory and Legal Director Steve Scarff reminded consumers that OTC medicines should only be used following the dosing instructions and warnings on the labels.

 

References

1. https://www.tga.gov.au/sites/default/files/medicines-review-nsaid.pdf (at page 65)  

2. https://www.tga.gov.au/publication-issue/medicines-safety-update-volume-6-number-2-april-2015