Công Phạt Loạn Nhịp Tim của Thuốc Dolasetron Bài này nói về một trong những thuốc trong mộṭ họ thuốc family rất thường dùng hàng ngày trong oncology để control NV nausea and vomiting..
Trang 1Công Phạt Loạn Nhịp Tim của
Thuốc Dolasetron
Bài này nói về một trong những thuốc trong mộṭ họ thuốc (family) rất thường dùng (hàng ngày) trong oncology để control NV (nausea and vomiting)
Thật sự đây là một họ thuốc xứng đáng là breakthrough (phá nghẽn) cho NV, vì trước đó, các thuốc khác không hiệu quả bằng
Warnings (Cảnh báo) này đáng nhớ về torsade de pointes và QT-prolongation
Về hypomagnesemia, complication này thường thấy trong khi dùng patinum-based chemotherapy (tubular wasting) Các descriptions v/v này bắt đầu xuất hiện khoảng đầu 1980, và không có gì mới, nhưng có thể rất nghiêm trọng (chính : cardio : arrhythmia, neuro : seizure)
Trang 2(note : nhiều bnhân của tôi đã chữa khỏi ung thư, nhưng hồi đó dùng CisPlatinum (hay carboPlat) và rồi phải uống Magnesium - replacement - suốt đời)
FDA Warns Against Injection Dolasetron Due to Risk for Heart Arrhythmias
Emma Hitt, PhD
Authors and Disclosures
Posted: 12/17/2010
December 17, 2010 — Dolasetron mesylate (Anzemet; Aventis Pharmaceuticals) should no longer be used for the prevention of chemotherapy-induced nausea and vomiting because of an increased risk for cardiac arrhythmias, the US Food and Drug Administration (FDA) announced today
New data from a manufacturer study requested by the FDA demonstrate that dolasetron injection can increase the risk for potentially fatal torsade de pointes and has been linked to a dose-dependent prolongation of the QT, PR, and QRS intervals on electrocardiogram
Trang 3"The FDA previously noted cardiovascular safety concerns which suggested [dolasetron] could cause QT prolongation, which can lead to a serious and sometimes fatal heart rhythm called torsade de pointes," according to the data summary accompanying the FDA's safety announcement
A randomized, placebo-controlled, crossover trial was conducted in
80 healthy adults and found that the difference in QT interval (corrected by using Fridericia's formula) compared with placebo was 14.1 ms and 36.6 ms for the 100-mg and 300-mg doses of dolasetron, respectively Prolongation
of the PR and QRS interval was also noted in patients receiving dolasetron
in the same study on day 4
"Based on exposure-response analyses, QT, QRS, and PR interval prolongations appear to be associated with higher concentrations of Anzemet's active metabolite, hydrodolasetron," the FDA concludes
According to the data summary, patients at "particular risk for serious abnormal rhythms are those with underlying structural heart disease and preexisting conduction system abnormalities, the elderly, patients with sick sinus syndrome, patients with atrial fibrillation with slow ventricular response, patients with myocardial ischemia or patients receiving drugs
Trang 4known to prolong the PR interval (such as verapamil) and QRS interval (such as flecainide or quinidine)."
The data showing prolonged QT interval in adults were extrapolated
to a pediatric population using modeling and simulation, and interval length was also predicted to be longer with its use for chemotherapy-induced nausea and vomiting in this setting
The FDA advises that healthcare professionals should correct for hypokalemia and hypomagnesemia before administering this agent and that these electrolytes should be monitored after administration, as clinically indicated
No dose adjustment is necessary for renally impaired patients, hepatic-impaired patients, or the elderly; however, certain patients should be monitored with electrocardiogram, including those with congestive heart failure, with bradycardia, with underlying heart disease, the elderly, and patients who are renally impaired
The warning only applies to the injection form and not the tablet form
of dolasetron The risk of developing an abnormal heart rhythm with the oral form of this drug is less than that observed with the injection form, although
Trang 5a stronger warning about this potential risk is being added to the warnings and precautions sections of the dolasetron tablet label
The FDA also emphasizes that the notice only applies to the use of dolasetron in chemotherapy-induced nausea and vomiting At a lower dose, such as that used for postoperative nausea and vomiting, this agent is less likely to impair the electrical functioning of the heart and cause arrhythmia, and the injection form may still be used for this indication
More information about today's announcement is available on the FDA Web site
NTM
Disclaimer: bài này qúy vị có thể phổ biến tự do, không cần xin phép tác giả (Nguyễn Tài Mai), chỉ cần đề: bài do BS Nguyễn Tài Mai, đăng trên diễn đàn y sĩ ngày 17 tháng 12 năm 2010 (tôi không giữ lại bản đã viết, cho nên nếu có câu hỏi xin kèm bài này để dẫn chứng) Việc chữa bệnh từng bệnh nhân riêng biệt dĩ nhiên hoàn toàn tùy thuộc y sĩ điều trị, y sĩ máu, y sĩ ung thư của trường hợp đó
Bs Nguyễn tài Mai