|
Incretin Mimetic Drugs for Type 2 Diabetes: Early Communication - Reports of Possible Increased Risk of Pancreatitis and Pre-cancerous Findings of the Pancreas
AUDIENCE: Gastroenterology, Endocrinology, Oncology, Patient
ISSUE: FDA is evaluating unpublished new findings by a group of academic researchers that suggest an increased risk of pancreatitis and pre-cancerous cellular changes called pancreatic duct metaplasia in patients with type 2 diabetes treated with a class of drugs called incretin mimetics. These findings were based on examination of a small number of pancreatic tissue specimens taken from patients after they died from unspecified causes. FDA has asked the researchers to provide the methodology used to collect and study these specimens and to provide the tissue samples so the Agency can further investigate potential pancreatic toxicity associated with the incretin mimetics.
BACKGROUND: Drugs in the incretin mimetic class include exenatide (Byetta, Bydureon), liraglutide (Victoza), sitagliptin (Januvia, Janumet, Janumet XR, Juvisync), saxagliptin (Onglyza, Kombiglyze XR), alogliptin (Nesina, Kazano, Oseni), and linagliptin (Tradjenta, Jentadueto). These drugs work by mimicking the incretin hormones that the body usually produces naturally to stimulate the release of insulin in response to a meal. They are used along with diet and exercise to lower blood sugar in adults with type 2 diabetes.
RECOMMENDATIONS: FDA has not reached any new conclusions about safety risks with incretin mimetic drugs. This early communication is intended only to inform the public and health care professionals that the Agency intends to obtain and evaluate this new information. FDA will participate in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and National Cancer Institute's (NCI) Workshop on Pancreatitis-Diabetes-Pancreatic Cancer in June 2013 to gather and share additional information. FDA will communicate its final conclusions and recommendations when its review is complete or when the Agency has additional information to report.
The Warnings and Precautions section of drug labels and patient Medication Guides for incretin mimetics contain warnings about the risk of acute pancreatitis. FDA has not previously communicated about the potential risk of pre-cancerous findings of the pancreas with incretin mimetics. FDA has not concluded these drugs may cause or contribute to the development of pancreatic cancer.
At this time, patients should continue to take their medicine as directed until they talk to their health care professional, and health care professionals should continue to follow the prescribing recommendations in the drug labels.
Read the complete MedWatch Safety Alert, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA評估一群學者未公開的研究結果，該結果指出第二型糖尿病病人使用腸促胰島素分泌素類似物（incretin mimetics）治療可能會增加胰臟炎以及一種癌症前期之細胞病變：胰導管化生。此發現是由一群不明原因死亡之病人體內取出少量胰臟組織的檢驗結果。 FDA已要求研究人員提供收集和研究該樣本之方法及組織，以便相關單位能進一步調查腸促胰島素分泌素類似物之潛在毒性。
此類藥品成分包含exenatide、liraglutide、sitagliptin、saxagliptin、alogliptin和 linagliptin。該類成份藥品為透過模擬體內之腸促胰島素分泌素的作用刺激胰島素分泌，可隨餐或運動後服用以降低血糖。
FDA目前對此類藥物之風險尚未有更進一步的結論。目前先初步告知醫療專業人員，相關機構正取得並評估此新訊息。FDA將參與2013年6月國家糖尿病、 消化及腎病學會（NIDDK）和國家癌症學會（NCI）舉辦之胰臟癌與糖尿病及胰臟癌研討會，以期能獲得更多資訊。FDA於完整審核後或有更進一步之資訊 將傳達最後之結論與建議。
目前已於腸促胰島素分泌素類似物之仿單上及病人用藥教育單張中加註可能發生急性胰臟炎之風險警語，FDA沒有發布此類藥物產生潛在性癌前病變之風險，因仍尚未確立該藥物是否會造成或導致胰臟癌。
已在服用此藥之病人應繼續依醫師指示服用，若有任何問題請與醫療專業人員連絡。醫療人員也應持續追蹤仿單上之開方建議。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm343805.htm
[Posted 03/15/2013]
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
|
資料來源：藥師週刊（第1816期）