Risk is outweighed by BP control benefit

WASHINGTON —The FDA approved label changes for hydroclorothiazide (HCTZ) to reflect an increased risk for non-melanoma skin cancer for patients taking the drug.

HCTZ, the most commonly prescribed diuretic for treatment of hypertension, is known to be associated with photosensitivity. Now, according to a study performed by the FDA’s Sentinel Initiative, use of the drug puts patients at risk for basal cell and squamous cell carcinomas, with the risk increasing as patients age and spend more time exposed to sunlight. However, the FDA emphasized that this risk does not trump the risks associated with uncontrolled hypertension.

The FDA study found, “increased risk was predominantly for squamous cell carcinoma (SCC) and in white patients taking large cumulative doses. The increased risk for SCC in the overall population was approximately 1 additional case per 16,000 patients per year, and for white patients taking a cumulative dose of ≥50,000mg the risk increase was approximately 1 additional SCC case for every 6,700 patients per year.”

“In addition, treatment for non-melanoma skin cancer is typically local and successful, with very low rates of death,” the agency noted. “Meanwhile, the risks of uncontrolled blood pressure can be severe and include life-threatening heart attacks or stroke. Given this information, patients should continue to use HCTZ and take protective skin care measures to reduce their risk of non-melanoma skin cancer, unless directed otherwise from their health care provider.”

To help offset the risks involved with HCTZ use, the updated label contains instructions advising patients to protect their skin from the sun as much as possible and undergo regular skin cancer screenings. To reduce overall sun exposure, the FDA suggested patients use broad spectrum sunscreens “with a sun protection factor value of at least 15” and limit time spent in direct sun. The agency also advised that patients on HCTZ wear protective clothing, sunglasses, and brimmed hats to keep the sun off their skin.

John McKenna, Associate Editor, BreakingMED™

Cat ID: 725

Topic ID: 88,725,730,6,11,26,192,725