Distribution of smoking cessation medication paused due to “impurity concerns”
Distribution of the smoking cessation medication Champix (Varenicline) has been paused in Australia as further testing of the medication is undertaken, its manufacturer claims.
It is currently on backorder in Australia as testing occurs for “impurity concerns”, as reported earlier this week by industry newsletter Pharma In Focus.
Champix manufacturer Pfizer says: “Varenicline tartrate available as Champix in Australia, a medication indicated for use as an aid to smoking cessation in adults over the age of 18 years, is currently on backorder, because of a disruption in the distribution of the medicine.”
In a statement provided to AJP, Pfizer said it had paused distribution of Champix in Australia “out of an abundance of caution…. pending further testing”.
“We are working to expedite the testing and progress discussions with the Therapeutic Goods Administration (TGA) as quickly as possible,” Pfizer said.
“While Pfizer is managing this distribution disruption with urgency, at this time we are unable to confirm a date when the situation will be resolved.
“Ensuring continuity of the supply of our medicines is paramount. Until the shortage is resolved, patients are recommended to consult with their healthcare professional to choose an alternate treatment option.”
According to the Pharma In Focus report, the pause was undertaken after elevated levels of nitrosamines, a likely carcinogen, in Champix tablets. No locally available batches are understood to have been recalled, the report said.
In a statement, the TGA said it was “aware of the issue and is working with Pfizer and our international regulatory counterparts to investigate and address this issue. Patients who are affected should talk to their doctors about their treatment options”.