NSAID labelling review
The TGA has announced it will be reviewing product information and labelling for non-steroidal anti-inflammatory drugs.
The review will include diclofenac, naproxen, ibuprofen, celecoxib, etoricoxib, indomethacin, meloxicam and piroxicam.
These changes follow from a review of the cardiovascular risks associated with the use of these medicines and a full safety review of diclofenac.
While use of NSAIDs at prescription-only dosages was already known to increase the risk of high blood pressure, heart failure, myocardial infarction and stroke, the TGA review found that these risks also applied to oral diclofenac, naproxen and ibuprofen available OTC.
Similarly, the risk of hepatotoxicity in relation to use of prescription diclofenac was known, but the diclofenac safety review found that oral products available OTC also carried this risk.
The reviews found that use of OTC NSAIDs was safe when they were used according to the recommended doses for short durations, as instructed on the label.
“However, inappropriate use or overuse of these medicines could pose a significant risk of cardiovascular events and, in the case of diclofenac, hepatotoxicity”.
Health professionals should “consider advising patients of the increased cardiovascular risks of using NSAIDs, including OTC products, and educating them regarding the signs and symptoms of serious cardiovascular events,” the TGA advises.
“Be aware that, in rare cases, diclofenac has been associated with a risk of hepatotoxicity and should be used at the lowest effective dose for only short periods of time”.
PI update for valdoxan
The Product Information (PI) for agomelatine 25 mg, marketed in Australia as Valdoxan, has been updated to include further information about the risk of hepatic injury.
The most recent update to the PI clarifies and expands on changes made in December 2013. It includes additional information in the precautions and dosage and administration sections regarding monitoring of liver function.
New HIV medicine on PBS
A new HIV medicine has been added to the PBS, increasing the range of treatment options available for people living with HIV in Australia.
From 1 April 2015, the new HIV antiviral medication Triumeq (dolutegravir 50mg / abacavir 600mg / lamivudine 300mg) will be available through the PBS.
Triumeq is a once daily tablet combing three antiviral medications dolutegravir, abacavir and lamivudine. It is the first single-pill therapy to become available which contains dolutegravir.
It is available to treat HIV in adults and adolescents from 12 years of age who are antiretroviral treatment naïve or are infected with HIV without documented or clinically suspected resistance to any of the three antiretroviral agents.
Product Information is available from ViiV Healthcare Australia here or on 1800 499 226.