Use of Hydrochlorothiazide in the United States Following Label Update About Skin Cancer Risk

Area of Science:

• Pharmacovigilance
• Epidemiology
• Public Health

Background:

• The U.S. Food and Drug Administration (FDA) issued a Drug Safety Communication (DSC) on August 20, 2020, regarding a potential increased risk of non-melanoma skin cancer (NMSC) linked to hydrochlorothiazide (HCTZ) use.
• Labeling updates accompanied the DSC to inform healthcare providers and patients about this risk.

Purpose of the Study:

• To evaluate the impact of the FDA's DSC on the utilization patterns of hydrochlorothiazide (HCTZ) in the United States.
• To assess whether the safety communication influenced prescribing habits for HCTZ, particularly concerning its association with NMSC.

Main Methods:

• A trend analysis was performed using the Sentinel Distributed Database, analyzing national healthcare administrative data from January 2017 to November 2022.
• Two cohorts were defined: an overall patient cohort and a cohort with a history of NMSC. Monthly proportions of HCTZ use among thiazide diuretic users were plotted and analyzed using interrupted time series.
• Secondary analyses examined HCTZ use among all antihypertensive users.

Main Results:

• The DSC was associated with a statistically significant but clinically negligible trend change (0.018%) in monthly HCTZ proportion in the overall cohort.
• Similar negligible changes were observed in the skin cancer cohort, and secondary analyses revealed no significant changes in HCTZ use among antihypertensive users post-DSC.

Conclusions:

• No significant changes in hydrochlorothiazide (HCTZ) use were detected following the FDA's Drug Safety Communication regarding its non-melanoma skin cancer (NMSC) risk.
• The findings suggest that the safety communication did not substantially alter HCTZ prescribing patterns in the U.S. population, aligning with the DSC's recommendations.