Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study -Pub

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A very interesting epidemiology research on the use of Valsartan, Losartan and Irbesartan pre and post Nitrosamines event.

“Valsartan, Losartan and Irbesartan use in the USA, UK, Canada and Denmark after the nitrosamine recalls: a descriptive cohort study” by Eworuke et al.

Access: https://bmjopen.bmj.com/content/13/4/e070985

Abstract:

Objectives To examine valsartan, losartan and irbesartan usage and switching patterns in the USA, UK, Canada and Denmark before and after July 2018, when the first Angiotensin-Receptor-Blocker (ARB) (valsartan) was recalled.

Design Retrospective cohort study.

Setting USA, Canadian administrative healthcare data, Danish National Prescription Registry and UK primary care electronic health records.

Participants Patients aged 18 years and older between January 2014 and December 2020.

Intervention Valsartan, losartan and irbesartan.

Main outcome Monthly percentages of individual ARB episodes, new users and switches to another ARB, ACE inhibitors (ACEI) or calcium channel blockers containing products.

Results We identified 10.8, 3.2, 1.8 and 1.2 million ARB users in the USA, UK, Canada and Denmark, respectively. Overall proportions of valsartan, losartan and irbesartan use were 18.4%, 67.9% and 5.2% in the USA; 3.1%, 48.3% and 10.2% in the UK, 16.3%, 11.4% and 18.3% in Canada, 1%, 93.5% and 0.6% in Denmark. In July 2018, we observed an immediate steep decline in the proportion of valsartan use in the USA and Canada. A similar trend was observed in Denmark; however, the decline was only minimal. We observed no change in trends of ARB use in the UK. Accompanying the valsartan decline was an increase in switching to other ARBs in the USA, Canada and Denmark. There was a small increase in switching to ACEI relative to the valsartan-to-other-ARBs switch. We also observed increased switching from other affected ARBs, losartan and irbesartan, to other ARBs throughout 2019, in the USA and Canada, although the usage trends in the USA remained unchanged.

Conclusion The first recall notice for valsartan resulted in substantial decline in usage due to increased switching to other ARBs. Subsequent notices for losartan and irbesartan were also associated with increased switching around the time of the recall, however, overall usage trends remained unchanged.

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When talking about recalls and pre- and post-2018 thinking/trends:
This is another nice recent example of data analysis with a recall data link:
The continuing challenge of drug recalls: Insights from a ten-year FDA data analysis - ScienceDirect
Showing the weight of nitrosamine related recalls in impurity-related recalls and overall recalls and the peaks of 2018-2019 for US.
16% of recalls are impurity related and 3.4% of these related to nitrosamines for 2012-2023 in USA. 22% of impurity recalls over a 10 year period link to nitrosamines.
The authors argue that the charts don’t show the nitrosamine issue has been solved.

“A total of 3 718 recall events were classified by the FDA during the specified period (8th of June 2012 until 30th of September 2023). A total of 584 recall events were caused by the presence of drug and process related impurities, corresponding to 15.7% of all recall events (15.7%, 584/3 718). 126 of them were related to the presence of the carcinogenic N-nitrosamine derivatives (3.38%, 126/3 718), of which the first recall event was initiated in 2018. A further classification of the different impurities was not possible due to the limited information made available in the database.”

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