Hydrochlorothiazide Receives Label Update

August 20, 2020 – The U.S. FDA has approved label changes for products that contain hydrochlorothiazide (HCTZ). The changes advise patients and healthcare professionals of a small increased risk of non-melanoma skin cancer (basal cell skin cancer or squamous cell carcinoma) associated with use of the drug.

HCTZ is used to treat a variety of conditions, including high blood pressure, heart failure, and diabetes insipidus. In a clinical study, the increased risk of skin cancer associated with HCTZ use was primarily seen in the form of squamous cell carcinoma (SCC). In the study population, use of HCTZ increased the risk of SCC by approximately one additional case per 16,000 patients per year.

Both basal cell skin cancer and SCC can typically be cured when caught early and are rarely fatal. The risk of developing these diseases may be higher in patients who use HCTZ products because HCTZ is associated with increased skin sensitivity to light. Patients can manage or reduce their risk by regularly wearing sunscreen and clothing that protects them from the sun, limiting sun exposure, and undergoing regular skin cancer screenings. The FDA advises patients continue to use HCTZ as prescribed while taking protective skin care measures, as the risks of not using the medication can be severe and life-threatening.

The full drug safety and label change notice for HCTZ can be found on the FDA’s website.