We think you are in Victoria. If not please click 'Change'

In your state, you are required to confirm you wish to access this information. Please enter 'QLD' or 'WA' in the field below to continue.

No thanks

TGA investigates anti-inflammatory drugs

Meeting silhouette | Shine Lawyers

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:

  1. safety at low doses,
  2. short duration of treatment; and
  3. 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 on . Last modified: September 21, 2017.

Join the discussion

Share this article:

There are 0 comments. Be the first!

Faulty High-tech braking systems: Subaru and Honda Recalls

The safety of cars with automatic braking systems have been called into question with car manufactures issuing worldwide recalls in response to faulty program software. Car manufactures Subaru and Honda have announced large recalls due to malfunctioning technology designed to prevent rear-end crashes and avoid hitting pedestrians, yet instead are putting the vehicles at risk […]

Read more

China-Australia Free Trade Agreement: potential commercial implications

The China-Australia Free Trade Agreement (ChAFTA) was signed on the 17th June 2015, implementing a foundation in the next phase of inter-economic relationships between Australia and China. The potential for the ChAFTA to create opportunities for Australia is evident, with China accounting for Australia’s largest export market for goods and services and a nearly a […]

Read more

Breast implant suspended from Australian market

The Therapeutic Goods Association (TGA) has imposed a 6 month suspension on Cereform silicone gel-filled breast implants and associated sizers from the Australian Register of Therapeutic Goods. Since 2009, about 4800 of the implants were sold in Australia. The action taken by the TGA will now prevent the devices from being supplied to the Australian […]

Read more