The Therapeutic Goods Administration (TGA) has begun investigations into anti-inflammatory medication following suggestions that the drugs may increase the risk of suffering from a cardiovascular event such as a heart attack. The TGA’s investigations will establish whether these risks outweigh the benefits associated with the medication.
It was found that cardiovascular risks are increased even at low doses and after a short duration of treatment especially in patients with prior cardio-vascular disease or family history. The TGA maintains that extensive investigations and randomised trials have not been undertaken hence the findings in observational studies which suggest that this increased risk cannot be fully confirmed.
The TGA also carried out a review of over the counter anti-inflammatory drugs such as ibuprofen. Overall, the risks associated with over the counter and prescribed anti-inflammatory medication are similar. Current evidence also suggests that risks may be increased with dose and duration of treatment and may also be increased with concomitant use of low-dose aspirin.
In considering the risks associated with anti-inflammatory medication, the TGA has outlined three important considerations to keep in mind:
- safety at low doses,
- short duration of treatment; and
- awareness of patients with a background risk of CV disease.
The TGA has concluded that the labelling of over the counter products should include a warning that there may be an increased risk of serious cardiovascular events which may be fatal. Furthermore, that this risk may increase with duration of use, dosage amount and a history of cardio vascular events.
Written by Shine Lawyers. Last modified: April 18, 2019.