Hydrochlorothiazide Drug Label Change to Include Small Risk of Skin Cancer
Posted: Thursday, August 27, 2020
On August 20, the U.S. Food and Drug Administration (FDA) approved a drug label change to hydrochlorothiazide that includes mention of a small risk of non-melanoma skin cancer associated with drug use. The modified label also encourages patients to protect their skin from the sun and to undergo regular skin cancer screenings. Hydrochlorothiazide is a diuretic used in blood pressure treatments and has been linked to a slight increased sensitivity to sunlight.
The modified label was based on the results of an FDA Sentinel Initiative study, which discovered an increased risk mainly for squamous cell carcinoma when taking hydrochlorothiazide. In the overall study population, the increased risk for squamous cell carcinoma in patients treated with hydrochlorothiazide was approximately 1 additional case per 16,000 patients per year. Despite the small risk of skin cancer, the FDA recommends patients continue to use hydrochlorothiazide as prescribed and take protective skin-care measures to reduce their risk of non-melanoma skin cancer, unless directed otherwise by their health-care provider.
The FDA also recommends several skin cancer prevention methods, including using a broad-spectrum sunscreen with a sun protection factor value of at least 15, reapplying sunscreen regularly, and limiting the amount of time in the sun. Wearing protective clothing, sunglasses, and broad-brimmed hats is another way to avoid sun exposure.
For more information on changes to the hydrochlorothiazide drug label, visit accessdata.fda.gov.