Update: GSK announced UK and EU resupply of Zyban (bupropion) for December 2023, see this blog post for more details

This blog post discusses the continued shortage of the antidepressant and smoking cessation medication Bupropion, also known as Zyban, due to nitrosamine impurities. Alex notes that GSK has not yet issued a recall order for Zyban, despite doing so for other medications with similar impurities, and that the brand name has been discontinued in the US. The FDA has determined that the US withdrawal was not due to safety reasons, and GSK has not given an estimated recovery date. The UK government is aware of the supply shortage, and the Medicines and Healthcare products Regulatory Agency is blocking imports into the UK. Alex expresses concern about the possibility of GSK withdrawing the product altogether, and the lack of transparency in the industry.

It has been just over eight months since GSK announced they were halting the supply of Bupropion (the brand name is “Zyban”) due to nitrosamine impurities. Since my previous blog post about the supply shortage, I have heard very little.

Here is what I know:

  1. For some reason, GSK has not yet put out a recall order for Zyban. In every other case of medications with Nitrosame impurities that I know of, a recall order has been placed e.g. Champix
  2. The Zyban brand name has been discontinued in the U.S. (other brands are available)
  3. The FDA determined in Dec 2022 that the U.S. withdrawal was not due to safety reasons
  4. GSK has still not yet given an estimated recovery date
  5. The UK government is “aware” of the Bupropion supply shortage
  6. The MHRA is blocking imports into the UK (see Mar 2023 news post in hyperlink)
  7. The HSJ and the Daily Mail have reported on the shortage

Other than that. I know diddly squat.

I was really lucky to have sourced one of the very few legitimate supplies of Bupropion in the country. Though, I have had to do so privately. I’m paying nearly two and a half thousand pounds per year for the medication, and the cost is only going to keep going up.

I am most fearful of GSK withdrawing the product altogether. I am worried they see Bupropion as non-profitable for use as a smoking aid. I have heard a rumour going around from some pharmacists that the nitrosamine announcement was a ploy to get out of their NHS contract. However, I think this is now entering conspiracy theory territory.

Inviting scrutiny from the UK medicines agency about cancer-causing chemicals in your drug doesn’t seem like the wisest move to get out of a government contract, but, who knows?

Given the amount of time for Pfizer to change their manufacturing procedure to get Champix back on the market (Supply stopped from Oct 2021 – approx. end of 2023), it seems like the wait is going to be years, not months.

I expect a notice will just pop up one day saying that either Zyban is back, or has been discontinued, just like the original GSK December 2022 Zyban supply stoppage notice.

How does this industry get away with this immoral non-transparent secrecy rubbish? Even the rail industry has to provide a replacement bus service every time there is a problem with a line.

The only reason this type of behaviour is allowed is because it has always been allowed. Oh well. One problem at a time I suppose.

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