News Brief: Non-melanoma Skin Cancer Warning Added to Hydrochlorothiazide Drug Label

Hydrochlorothiazide (MICROZIDE) is a thiazide diuretic drug (“water pill”) commonly used to treat hypertension (high blood pressure), congestive heart failure and other conditions. A thiazide diuretic in general is the best first-line option for treating hypertension.

On Aug. 20, 2020, the Food and Drug Administration (FDA) approved changes to the drug label for hydrochlorothiazide to warn about a small increased risk of non-melanoma skin cancer with use of the drug (approximately one additional case per 16,000 patients per year).[1] There are two types of non-melanoma skin cancer: basal cell skin cancer and squamous cell skin cancer. Both types typically can be treated successfully and thus have very low death rates.

In contrast, the adverse effects of uncontrolled hypertension, including heart attacks and stroke, often are severe and even life-threatening. For this reason, the FDA does not advise stopping treatment with hydrochlorothiazide because of this skin cancer risk. Instead, patients should continue to take the drug and take steps to protect their skin from sun exposure, such as limiting time in the sun, wearing protective clothing and using a broad-spectrum sunscreen with a sun protection factor (SPF) of at least 15.

For more tips on how to protect your skin from harmful sun exposure, visit the FDA website at https://www.fda.gov/consumers/consumer-updates/tips-stay-safe-sun-sunscreen-sunglasses.
 

References

[1] Food and Drug Administration. FDA approves label changes to hydrochlorothiazide to describe small risk of non-melanoma skin cancer. August 20, 2020. https://www.fda.gov/drugs/drug-safety-and-availability/fda-approves-label-changes-hydrochlorothiazide-describe-small-risk-non-melanoma-skin-cancer. Accessed November 18, 2020.