關於bevacizumab (Avastin®)和dronedarone (Multaq®)安全性的最新資訊 Latest safety updates on bevacizumab (Avastin®) and dronedarone (Multaq®)

  •  Bevacizumab (Avastin®)可能導致卵巢不育   
           在一項名為NSABP C-08第三期臨床試驗的mFOLFOX6化療方案中, 加入了bevacizumab (Avastin®)作為結腸癌病人的輔助治療藥物。羅氏公司(Roche)根據上述試驗的結果, 表示相對於只處方mFOLFOX6的病人(2.6%), 併用bevacizumab與mFOLFOX6方案的停經前女性病人, 出現原發卵巢衰竭的個案較高(39%), 但在停用bevacizumab後, 86.2%女性的卵巢功能可恢復。化療是已知導致癌症病人卵巢衰竭的危險因子, 而動物實驗的重複劑量安全性研究亦顯示, bevacizumab可對卵巢功能產生與劑量成比例的可逆性抑制, 可能對女性的生育能力造成損害。
        目前, 對於將要接受bevacizumab治療的育齡女性病人, 建議衛生專業人士與她們討論是否採取保留生育能力的措施。

 

  • Dronedarone (Multaq®)與嚴重心血管事件
            Dronedarone (Multaq®)是一種用於陣發性心房纖顫或心房撲動病人的抗心律失常藥物, 減少病人因心血管事件而進院的風險, 美國食物及藥物管理局(USFDA)近期評估PALLAS臨床研究中dronedarone與嚴重心血管事件關聯性的數據。PALLAS的初步結果顯示, 相對於服用安慰劑的病人, 服用dronedarone的永久性心房纖顫病人出現中風﹑心臟衰竭而入院以及死亡的機率增加兩倍。目前並不確定該結果是否適用於以dronedarone治療非永久性心房纖顫的病人上, 在有進一步的結論前, 建議醫生﹑藥劑師及其他衛生專業人士：
  1. 不要向患有永久性心房纖顫的病人處方dronedarone。
  2. 與服用dronedarone的非永久性心房纖顫病人討論是否繼續服用該藥。
  3. 告訴病人不要在未經醫生同意下自行停藥。

 

  • Bevacizumab (Avastin®) may be associated to ovarian infertility
           Bevacizumab (Avastin®) was added to mFOLFOX6 in the NSABP C-08 Phase III trail to serve as an adjuvant treatment for patients with colon cancers.  Roche announced the results of her trial which indicated that a higher incidence of diagnosed new ovarian failure cases has been observed in premenopausal women who were given with bevacizumab + mFOLFOX6 combination (39%) as compared to those who were prescribed with mFOLFOX6 alone (2.6%).  Upon discontinuation of bevacizumab treatment, ovarian function recovered in 86.2% of evaluable women in the mFOLFOX6 + bevacizumab group.  Noting that chemotherapy is a known contributing risk factor for ovarian failure in cancer patients and repeated dose safety studies in animals have also shown that bevacizumab results in a dose- dependent reversible inhibition of ovarian function, which may have an adverse effect on female fertility.
            At this moment, healthcare professionals are advised to implement fertility preservation strategies and discuss with female patients of child-bearing potential prior to starting with bevacizumab.

 

  • Dronedarone (Multaq®) and severe cardiovascular events
            Dronedarone (Multaq®), an antiarrhythmics, is targeted to reduce the risk of cardiovascular hospitalization in patients with paroxysmal atrial fibrillation (AF) or atrial flutter (AFL).  United States and Food Administration (USFDA) is currently evaluating data obtained from the PALLAS Study regarding the association of dronedarone and the severe cardiovascular events.  Preliminary results from the PALLAS recognized a two-fold increase in death, as well as two-fold increases in stroke and hospitalization for heart failure in patients with permanent atrial fibrillation receiving dronedarone as compared to patients taking a placebo.  Whether the unfavorable results apply to patients who use dronedarone for the approved indication of non-permanent atrial fibrillation is not known.  Before the release of any conclusive results, physicians, pharmacists and healthcare professionals are advised with the following recommendations：
  1. do not prescribe dronedarone to patients with permanent atrial fibrillation.
  2. discuss with patients with non-permanent atrial fibrillation taking dronedarone about whether they should continue to take.
  3. counsel patients not stop taking the medication without talking to prescribing physician.

                               

                        參考資料/References and websites：                                            

                         https://www.hsa.gov.sg/publish/hsaportal/en/health_products_regulation/safety_information/DHCPL.html

                         https://www.fda.gov/Drugs/DrugSafety/ucm264059.htm

                         https://www.fda.gov/Drugs/DrugSafety/ucm263320.htm