The Food and Drug Administration (FDA) has approved labeling changes for hydrochlorothiazide to include additional safety information regarding an increased risk of non-melanoma skin cancer (basal cell skin cancer or squamous cell skin cancer).
According to an FDA Sentinel Initiative study, the increased risk was predominately for squamous cell carcinoma and in white patients taking large cumulative doses (ie, ≥50,000mg). Findings from the study showed that the increased risk for squamous cell carcinoma in the overall population was approximately 1 case per 16,000 patients per year.
Hydrochlorothiazide is indicated for the management of hypertension either as the sole therapeutic agent, or in combination with other antihypertensives. Weighing the benefits and risks of continued hydrochlorothiazide treatment, the FDA noted that the risks of uncontrolled hypertension can be severe and life-threatening, while the rates of death from non-melanoma skin cancer are generally low.
In a statement, the Agency reported that based on the study findings, the overall risk for non-melanoma skin cancer is small; however, the risk increases as patients age and with prolonged sun exposure. Patients taking hydrochlorothiazide should be instructed to protect their skin from the sun and undergo regular skin cancer screening. Additional information regarding sun protection and sunscreens can be found here.
For more information visit fda.gov.
FDA approves label changes to hydrochlorothiazide to describe small risk of non-melanoma skin cancer. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-label-changes-hydrochlorothiazide-describe-small-risk-non-melanoma-skin-cancer. Accessed August 21, 2020.