Study Examines Effect of Valsartan Recall

The valsartan recall "may have been associated with adverse unintended clinical effects of controlled hypertension," according to research published Nov. 11 in Circulation and will be presented during AHA 2019 in Philadelphia, PA.

Cynthia A. Jackevicius, BScPhm, PharmD, MSc, FACC, looked at patients 65 years or older who had been given a supply of at least one recalled valsartan product in Canada up until July 9, 2018 – the recall date of six generic valsartan products. Of the 55,461 patients in the sample, 95 percent had hypertension and 5 percent had heart failure.

Results showed that the majority of patients changed to a non-valsartan angiotensin-receptor-antagonist (73.8 percent) or a non-recalled valsartan product (8.8 percent) by one month after the recall. However, there was incomplete replacement of valsartan with alternative products and at 3 months and 10.7 percent of recalled valsartan users did not fill an alternative medication.

Further, there was an "immediate increase in ED visits for hypertension, and a delayed increase in ED visits and hospitalizations for stroke/TIA following the recall."

The researchers conclude that their results "highlight the potential burden and risks associated with recalls of chronic oral medications used by large populations."

Clinical Topics: Prevention

Keywords: AHA19, AHA Annual Scientific Sessions, Primary Prevention

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