Ranitidine Recalls Affected Hundreds of Thousand of Patients in US, Canada

The ranitidine shortage, prompted by a nitrosamine impurity detected in September 2019 that led to recalls of the drug in the US and Canada, caused immediate and sustained shifts in the use of histamine-2 receptor antagonists, according to a study published in Digestive Diseases and Sciences.

“We estimate that the ranitidine shortage may have affected hundreds of thousands of patients, involving health care resources to switch patients to alternate treatment,” wrote corresponding author Mina Tadrous, PharmD, of the University of Toronto, and study coauthors.

Before the ranitidine recalls, approximately 189 million ranitidine units were purchased monthly in the US and 20 million in Canada, according to the study. One month into the recalls, ranitidine purchasing rates dropped by 53% in the US and 99% in Canada. That same month, purchasing rates for non-ranitidine histamine-2 receptor antagonists increased 37.3% in the US and 128.3% in Canada.

The study found that purchasing rates for proton pump inhibitors after the start of ranitidine recalls did not change significantly in either country.

“Our results emphasize the need for future studies of the clinical and financial implications of the shortage,” researchers wrote, “and the importance of ongoing work to mitigate and prevent drug shortages.”

Reference

Gunning R, Chu C, Nakhla N, Kim KC, Suda KJ, Tadrous M. Major shifts in acid suppression drug utilization after the 2019 ranitidine recalls in Canada and United States. Dig Dis Sci. 2023;68(8):3259-3267. doi:10.1007/s10620-023-07958-6