Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication - FDA Requests Withdrawal of Weight-Loss Drug

以下是創益生技股份有限公司的聲明

​本公司(創益生技股份有限公司)，針對美國FDA於2020年2月13 日發布在美國合法上市的減肥藥沛麗婷處方藥（Belviq，學名Lorcaserin）因可能增加罹癌風險，衛采製藥(Eisai)決定退出美國市場一事，說明如下：
1、 美國FDA用藥安全聲明內容指出，雖無法斷定沛麗婷Belviq（學名Lorcaserin）會導致特定癌症，但於第四期臨床試驗Camellia Study (進行五年，一萬兩千人，平均年齡64歲，平均體重為102公斤中，試驗組與對照組罹癌人數比為7.7%與7.1%，兩組數據臨床統計上無顯著差異，但原廠衛采製藥(Eisai)基於病人安全為首要條件之下，仍決定沛麗婷Belviq退出美國市場販售。
2、 本公司對於原廠衛采製藥(Eisai)決定退出美國市場的原因與資訊，因東西方時差關係，正在尋求聯繫與了解中。
3、 基於病人安全為首要條件之下，本公司也將通知醫療院所先暫停開立沛麗婷Belviq處方籤。
4、 對於已經服用或者正在服用沛麗婷Belviq的患者請不用過度恐慌，根據FDA於2020年2年13日發布的用藥安全(DSC, Drug safety communication )裡已詳載請病患停藥即可，不需立即做額外追蹤處置。

​[Posted 02/13/2020]

AUDIENCE: Patient, Health Professional, Pharmacy

ISSUE: 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 Inc,. 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 is 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:

Mix the pills with an unappealing substance such as dirt, cat litter, or used coffee grounds; do not crush them.
Place the mixture in a container such as a sealed plastic bag.
Throw away the container in your trash at home.
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.

Health Professionals
Health professionals should stop prescribing and dispensing lorcaserin to patients. Contact patients currently taking lorcaserin, inform them of the increased occurrence of cancer seen in the clinical trial, and ask them to stop taking the medicine. Discuss alternative weight-loss medicines or strategies with your patients.

FDA is not recommending special screening for patients who have taken lorcaserin. As with any individual patient, regardless of prior lorcaserin treatment, standard screening recommendations for cancer should be implemented.

拿出家裡的電鍋，再放一個內鍋，然後放入戴過的外科口罩。

記得放垂直喔！(上面可以放筷子架著)
(不能直接讓表層接觸電鍋底部加熱板，破壞防護結構。)

外層不能加水！
(有水蒸氣的話，會嚴重破壞口罩的濾材，馬上就會下降50%的過濾效果。)

直接按下煮飯開關，大約3到4分鐘就好。

不影響外科口罩的過濾效力。

口罩取出來的時候呢，把它放到常溫，蒸過5次之後，它大概還有71.5%的過濾效果。
(建議只能復活3~4次)

還有噴酒精可消毒可否呢？

不建議用酒精來消毒口罩。

口罩表面噴灑酒精，酒精揮發前口罩都失去防水功能，等酒精揮發後，口罩又再度回復防水功能。

雖然酒精揮發後保有防水功能，但防菌功能是否還存在，不得而知。

記住！！千萬別戴上酒精未揮發的口罩，這樣恐會吸入更多粉塵與病菌。

政府防疫 #口罩
販售時間：
2/6下午2:00-4:00
下午2:00開始發號碼牌
2/7販售時間另行公布
-------------------------------
領取口罩時麻煩您：
1. 請依指示排隊 不准插隊
2. 請自備零錢
3. 購買時需過卡，請耐心等候
4. 優先領藥客人如有口罩需求，請重新排隊
5. 每次進店1個人次
6. 不預留、不預售
​
收取的費用都是繳回國庫；完全是做志工，謝謝合作。
請體諒實行之初，網路系統不穩，
請耐心等候，
請勿喧嘩、咆哮、催促。
防疫共體時艱 健保社區藥局
無償支援政府防疫 台灣加油
優先禮讓給高風險族群
例如
這兩天沒有口罩但要回診的長輩
或醫療人員
我們無法請來領取的人提供證明
只能靠公德心跟同理心還有信任❤️
還有提醒大家
請大家把 #酒精棉片 留給胰島素病患
#新德大藥局
#台北市松山區饒河街204號