藥物警訊

Invokana and Invokamet (canagliflozin): Drug Safety Communication - New Information on Bone Fracture Risk and Decreased Bone Mineral Density

AUDIENCE: Endocrinology, Nursing, Family Practice

ISSUE: FDA has strengthened the warning for the type 2 diabetes medicine canagliflozin (Invokana, Invokamet) related to the increased risk of bone fractures, and added new information about decreased bone mineral density. To address these safety concerns, FDA added a new WARNING AND PRECAUTION and revised the ADVERSE REACTIONS section of the Invokana and Invokamet drug labels.

FDA is ontinuing to evaluate the risk of bone fractures with other drugs in the SGLT2 inhibitor class, including dapagliflozin (Farxiga, Xigduo XR) and empaglifozin (Jardiance, Glyxambi, Synjardy), to determine if additional label changes or studies are needed. Health care professionals and patients are urged to report side effects involving canagliflozin or other SGLT2 inhibitors to the FDA MedWatch program.

BACKGROUND: Canagliflozin is a prescription medicine used with diet and exercise to lower blood sugar in adults with type 2 diabetes. It belongs to a class of drugs called sodium-glucose cotransporter-2 (SGLT2) inhibitors. Canagliflozin is available as a single-ingredient product under the brand name Invokana and also in combination with the diabetes medicine metformin under the brand name Invokamet. Bone mineral density relates to the strength of a person's bones.

RECOMMENDATIONS: Health care professionals should consider factors that contribute to fracture risk prior to starting patients on canagliflozin. Patients should talk to their health care professionals about factors that may increase their risk for bone fracture. Patients should not stop or change their diabetes medicines without first talking to their health care professional. Additional information for Health Care Professionals:

‧ Bone fractures have been seen in patients taking the type 2 diabetes medicine canagliflozin.
‧ Fractures can occur as early as 12 weeks after starting canagliflozin.
‧ Canagliflozin has also been linked to decreases in bone mineral density at the hip and lower spine.
‧ Consider factors that contribute to fracture risk prior to initiating canagliflozin.
‧ Counsel patients about factors that may contribute to bone fracture risk.

Additional information for Patients:

Do not stop or change your diabetes medicines without first talking to your health care professional. When untreated, diabetes can lead to serious problems, including blindness, nerve and kidney damage, and heart disease.

Read the MedWatch safety alert, including a link to the FDA Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA發布有關第二型糖尿病藥品canagliflozin可能增加骨折風險及減少骨密度之安全警訊。此訊息原列於該成分藥品仿單之「副作用」欄位，此次將加註在「警語與注意事項」中。

Canagliflozin為治療第2型糖尿病之處方藥，屬SGLT2抑制劑 (sodium-glucose cotransporter-2 inhibitors)。目前市面上此成分藥品有單方製劑，也有與metformin合併之複方製劑。

依據近期臨床試驗結果發現，相較於安慰組，病人服用canagliflozin 12週後發生骨折機率增加，且可能使髖骨及腰椎之骨密度降低。美國FDA正持續評估其它同藥理機轉之SGLT2抑制劑如dapagliflozin和empaglifozin之風險以決定是否也需將此警訊列入仿單。

美國FDA提醒醫療人員在處方此藥前應先評估病人是否有骨折之危險因子，且需告知病人此藥品可能增加骨折風險。糖尿病若中斷治療可能導致嚴重的併發症，如視力、神經及腎臟功能損害和引發心臟疾病，故病人在未與醫療人員討論前，應勿自行停用或更改用藥。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
[Posted 09/11/2015]

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