9 November 2021
The TGA has just announced (9 Nov 2021) it is urgently working with international regulatory bodies to investigate new cases of nitrosamine impurities discovered in commercially manufactured medication.
This latest discovery comes after N-nitrosodimethylamine (NDMA), and other nitrosamines, were found in blood pressure ‘sartan’ medication in July 2018. And now the impurity has again been discovered in several commercially produced medications both here and overseas.
The new products, found to contain unacceptably high levels of nitrosamine impurities, are valsaratan products – marketed in Australia as anti-smoking medication, Champix.
Pfizer Australia, the sponsors of Champix, have stopped distributing the product while investigations are underway and the TGA have recalled two contaminated batches from Australian pharmacies.
According to TGA’s website, “Long-term exposure over a period of years to nitrosamines that exceed certain levels can increase the risk of developing cancer.”
“Given this, the aim is to eliminate or minimise the levels of nitrosamines present in affected medicines, as their presence is generally considered unacceptable from both quality and safety perspectives.”
Pharmacists have been asked to examine their stocks of Champix and if packets from the contaminated batches are found, to immediately dispose of the packets and contact the TGA.
Unacceptably high levels of N-nitrosodimethylamine (NDMA), and other nitrosamines, were found in ‘sartan’ blood pressure medicines in Australia in 2018. In 2019 they were found in metformin products and ranitidine products.
According to news agency Bloomberg, The U.S. Food and Drug Administration (FDA) has found that one valsaratan API manufacturer in India has, “… a flawed process for controlling the impurities”, and, “hasn’t adequately ensured a residue of impurities aren’t building up on production equipment, which can cross-contaminate subsequent batches.”
More information on the Australian valsaratan recall can be found on the TGA website.