Actos and Bladder Cancer - Ongoing Safety Review

[FDA MedWatch] Potential Increased Risk of Bladder Cancer

(편집자 주 - 한국릴리가 국내서 시판하는 당뇨병 치료제 '액토스 - Actos'의 심각한 부작용인 방광암에 대한 잠재적 가능성 상승을 미국 FDA가 발표한 내용입니다.)

Actos (액토스, 성분명: pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer

AUDIENCE: Endocrinology, Family Practice, Urology

ISSUE: FDA notified healthcare professionals and patients that the Agency is reviewing data from an ongoing, ten-year epidemiological study designed to evaluate whether Actos (액토스, 성분명: pioglitazone) is associated with an increased risk of bladder cancer.

Findings from studies in animals and humans suggest this is a potential safety risk that needs further study.

At this time, FDA has not concluded that Actos (액토스, 성분명: pioglitazone)increases the risk of bladder cancer.

Its review is ongoing, and the Agency will update the public when it has additional information.

BACKGROUND: The drug manufacturer, Takeda, conducted a planned analysis of the study data at the five-year mark, and submitted their results to FDA.

Overall, there was no statistically significant association between Actos exposure and bladder cancer risk.

However, further analyses were also performed looking at how long patients were on Actos and the total amount of the drug they received during that time.

An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.

RECOMMENDATIONS: Healthcare professionals should continue to follow the recommendations in the drug label when prescribing Actos.

Patients should continue taking Actos unless told otherwise by their healthcare professional.

Patients who are concerned about the possible risks associated with using Actos should talk to their healthcare professional.