Episode 32: Champix / Varenicline recall

Kara Joyce: Hi everyone, and welcome to the NPS MedicineWise podcast. My name is Kara Joyce, and I'm a pharmacist, and I work for NPS MedicineWise as an educational visitor, and a clinical program officer. You might remember me from previous podcasts on psychotropics in aged care.

Joining me today, I have our medical advisor and usual podcast co-host Dr. Anna Samecki, to discuss the recent recall of Champix or otherwise known as varenicline, which you may know is a medicine used in the management of smoking cessation.

Hi Anna.

Dr. Anna Sameck...: Hi Kara, thanks for having me. I hope I've kept that host chair warm enough for you. Look, it's pretty exciting to be on the other end this time, sitting in the hot seat, and answering the questions. So, let's get this show on the road.

Kara Joyce: Sounds great. Great to have you on.

So, smoking and smoking cessation has been quite topical lately. You may have heard there were recent changes to nicotine prescribing coming into effect the 1st of October. And these will mainly effect vaping products. For those who aren't familiar with the proposed changes, we did record two special episodes recently. And you can find them on our website, and they feature Adjunct Professor John Skerritt from the TGA, and Professor Nicholas Zwar from Bond University.

But that's not the only change affecting smoking and smoking cessation. And our podcast today is to raise awareness about the recent supply chain issues and factory recall of varenicline.

Anna, can you take us through what's happened?

Dr. Anna Sameck...: Yeah, sure. So, essentially the TGA sent out an alert on the 5th of August, advising that varenicline, which is marketed as Champix, is being investigated over concerns of potential low levels of contamination with a compound called, and forgive me this is a mouthful, N-nitrosovarenicline. This is on the back of the TGA becoming aware that very low levels of this compound had been detected in some Australian varenicline products. So, what's happened is that, as a precaution, the global distribution of varenicline, or Champix by Pfizer has been paused while the product is investigated.

Now, the supply impact dates, as far as we know from the TGA, will be until the 31st of December. Meaning that new supply probably won't resume until next year. In addition, there are recalls on certain batches. And, again according to the TGA, it appears that two batches have been specifically recalled due to concerns over unacceptable levels of this compound in the medicine. So, pharmacies that were supplied these, I guess, tainted batches would have been alerted.

Having said that though, there is probably still a number of pharmacies in the community that would have available batches and stock, which was not recalled. So, there is a proportion of patients who still have access to varenicline. But what we essentially want to raise today, and raise awareness about is that this un-recalled stock is limited. And supply of new stock, again, won't resume until next year, as already mentioned. So, what does that mean for patients? Well, it means varenicline may not be an option in the foreseeable future for some new patients looking to pharmacotherapy for smoking cessation. And it's also likely to impact patients already on this medicine. So, again, it's important health professionals begin to have discussions with their regular patients about ongoing management of smoking cessation. And have a plan in place, at least for the remainder of the year, as to how these patients will be managed.

Kara Joyce: Thanks for the explanation, Anna. I'm sure our listeners really appreciate the update, particularly as it's not something that a lot of health professionals knew about. We've had a lot of feedback around that.

You mentioned the recall was due to concerns of this compound, N-nitroso varenicline. Can you tell us a bit more about it?

Dr. Anna Sameck...: I can. So, N-nitroso varenicline, it is a mouthful, isn't it? It's a nitrosamine, essentially, that means it's an organic compound that has been linked to [00:04:00] the risk of developing certain cancers. Now, nitrosamines are not that uncommon and can be found in low levels in the environment such as in air pollution, but also in some foods, especially smoked meats. So, for our listeners out there who like a lot of smoked meats, just be aware.

But, interestingly, this is not the first time the TGA has investigated certain medicines or products over concerns of nitrosamine contamination. So, you might recall back in 2018, the 'sartan class of blood pressure medicines was investigated. And in 2019, some metformin and ranitidine products were also investigated due to nitrosamine impurities.

In the case of varenicline though, contamination appears to be an issue with the manufacturing. So, it appears that it's specific to the process of making the medicine itself. Now, we don't know exactly at this stage what the TGA or Pfizer will do. But it's more than likely that they will look into the manufacturing [00:05:00] process to see whether this contamination can be avoided before new supply is reinstated globally.

Kara Joyce: It definitely does seem like this recall is necessary, but it comes at a really difficult time. The pandemic has been extremely challenging for health professionals, and patients alike. And there's no doubt that the medicine shortage coupled with the new nicotine prescribing changes will affect the way smoking cessation is managed.

On that note, I'd like to point our listeners to the resources we'll be linking, along with our podcast, which includes a few resources on smoking cessation options, as well as nicotine prescribing changes again.

And I've also heard from a little birdie, Anna that this will be your last podcast for some time.

Dr. Anna Sameck...: Yeah, that's right, Kara. So, the secret's out, I'm on maternity leave after this week. So, we'll be handing over the host chair to our new medical advisor, Dr. Caroline West, who I want to warmly welcome to the NPS MedicineWise community and family.

I guess, I'd also like to take this opportunity quickly to say thank you to all our staff, including our media team, yourself, Kara, all of our podcasts interviewees over the last 18 to 12 months... Or 12 to 18 months, gosh that's baby brain for you, who have done an incredible job in bringing our listeners the latest updates around the quality use of medicines and medical tests. So, thanks again. And I look forward to seeing you in maybe six to eight months' time.

Kara Joyce: Thanks so much, Anna. I know I've really enjoyed listening to your podcast. And thank you again for joining us today. And thank you to our listeners. If you have any questions or suggestions for our podcast, including any topics that you want to hear more about, please send us an email, or reach out by Twitter or LinkedIn. Thanks everyone.