Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication - FDA Requests Withdrawal of Weight-Loss Drug (1)
[Posted 02/13/2020]
AUDIENCE: Patient, Health Professional, Pharmacy
ISSUE: The FDA has requested that the manufacturer of Belviq, Belviq XR (lorcaserin) voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai, has submitted a request to voluntarily withdraw the drug.
When FDA approved lorcaserin in 2012, we required the drug manufacturer to conduct a clinical trial to evaluate the risk of cardiovascular problems. A range of cancer types was reported, with several different types of cancers occurring more frequently in the lorcaserin group, including pancreatic, colorectal, and lung.
BACKGROUND: In January 2020, FDA announced we were reviewing clinical trial data and alerted the public about a possible risk of cancer associated with lorcaserin based on preliminary analysis of the data.
RECOMMENDATION:
Patients
Patients should stop taking lorcaserin and talk to your health professionals about alternative weight-loss medicines and weight management programs. It's best to dispose of unused lorcaserin using a drug take back location, but if you can’t get to one you can dispose of lorcaserin in your household trash:
1. Mix the pills with an unappealing substance such as dirt, cat litter, or used coffee grounds; do not crush them.
2. Place the mixture in a container such as a sealed plastic bag.
3. Throw away the container in your trash at home.
4. Remove or delete all personal information on the prescription label of empty medicine bottles or packaging, then throw away or recycle them.
FDA is not recommending special screening for patients who have taken lorcaserin. Talk to your health care professional if you have questions.
美國FDA在2012年核准lorcaserin上市時，已要求廠商進行臨床試驗以評估心血管疾病的風險。根據臨床試驗之結果，在lorcaserin組中通報癌症的案例較多，包含胰腺癌、結直腸癌和肺癌等不同種類的癌症。2020年1月，美國FDA宣布目前正在審查臨床試驗的資料，並根據初步分析的結果，向大眾發出lorcaserin相關的癌症風險的藥物安全警訊。美國FDA要求Belviq、Belviq XR（lorcaserin）的製造商自主性將該減肥藥物從美國下架，因為一確認安全性的臨床試驗顯示使用此藥可能增加癌症的發生率。藥品製造商Eisai已向美國FDA提交此藥品自主性下架之要求。
FDA建議如下：
病人：
病人應停止服用lorcaserin，並與醫療專業人員討論替代的減肥藥和體重管理計劃。尚未使用完的lorcaserin，建議依照美國廢棄藥品回收的方式至指定地點處理，若無法至指定地點，亦可將lorcaserin丟入家庭垃圾中，處理方法為：
1.將藥錠混入灰塵、貓砂或用過的咖啡渣等物質混合；勿將藥錠磨碎。
2.將上述混合物放入像密封的塑膠袋等容器中。
3.將此容器丟到家中一般垃圾桶中。
4.將空藥瓶或包裝上的個人處方標籤訊息移除後，再丟棄或回收。
美國FDA不建議針對已使用lorcaserin之病人進行特殊篩檢。如有疑慮，請洽醫療專業人員。
更多相關訊息與連結請參考FDA網址：https://reurl.cc/QdbZe5
（待續）
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
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