Pioglitazone-containing Medicines: Drug Safety Communication - Updated FDA Review, Increased Risk of Bladder Cancer
Includes Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni
AUDIENCE: Internal Medicine, Endocrinology, Urology
ISSUE: As a result of an updated review, the FDA has concluded that use of the type 2 diabetes medicine pioglitazone (Actos, Actoplus Met, Actoplus Met XR, Duetact, Oseni) may be linked to an increased risk of bladder cancer. The labels of pioglitazone-containing medicines already contain warnings about this risk, and FDA has approved label updates to describe the additional studies reviewed. See the FDA Drug Safety Communication for more details, including a data summary.
BACKGROUND: FDA alerted the public about the possible risk of bladder cancer in September 2010 and June 2011 based on interim results from a 10-year epidemiologic study. FDA changed the labels of pioglitazone-containing medicines in August 2011 to include warnings about this risk, and required the manufacturer to modify and continue the 10-year study.
Pioglitazone is approved to improve blood sugar control, along with diet and exercise, in adults with type 2 diabetes. Pioglitazone works by increasing the body's sensitivity to insulin, a natural hormone that helps control blood sugar levels. Untreated, type 2 diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.
RECOMMENDATION: Health care professionals should not use pioglitazone in patients with active bladder cancer, and should carefully consider the benefits and risks before using pioglitazone in patients with a history of bladder cancer.
Patients should contact their health care professionals if they experience any of the following signs or symptoms after starting pioglitazone, as these may be due to bladder cancer:
‧ Blood or a red color in the urine
‧ New or worsening urge to urinate
‧ Pain when urinating
Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm532772.htm
Pioglitazone可合併運動與飲食控制，治療第二型糖尿病病人，以改善血糖的控制。其作用機轉為增加身體對於胰島素(insulin)分泌的敏感性。美國FDA發布藥品安全警訊，使用第二型糖尿病藥物pioglitazone會增加發生膀胱癌的風險，並已於仿單加註此警訊及其相關研究等資訊。
美國FDA建議醫療專業人員不宜開立pioglitazone於膀胱癌病人身上；對於有膀胱癌病史的病人，若需開立此藥，需謹慎評估利弊再開方。並提醒病人使用pioglitazone時，若出現血尿或尿液偏紅；出現尿急感；排尿時有疼痛感，請主動與醫療專業人員連絡。
相關訊息與連結請參考美國FDA網址：
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm532772.htm
[Posted 12/12/2016]
資料來源：美國FDA之藥物安全警訊
資料提供：台大醫院藥劑部
回首頁 |