關於atomoxetine (Strattera®)安全性的最新資訊 Latest safety update on atomoxetine (Strattera®)


  •       Atomoxetine (Strattera®)是選擇性去甲腎上腺素重吸收抑制劑, 用於治療兒童及成人的注意力缺乏過動綜合症(ADHD), 加拿大衛生部(Health Canada)與禮來公司(Eli Lilly)通知衛生專業人士關於使用該藥可引致血壓升高及心跳加快的風險。近期一項由禮來公司贊助的合併了受控及非受控臨床試驗數據的分析結果發現, 使用atomoxetine的兒童病人中, 約25%的血壓升高了10mmHg, 而升高20mmHg的亦有5-8%, 同時33%的病人心跳加快了10bpm, 12%的病人則加快了20bpm, 對於某些病人而言, 這些改變可能會造成風險。更新了的資訊建議醫生﹑藥劑師及其他衛生專業人士:
  1. atomoxetine禁用於具症狀的心血管疾病﹑中至重度高血壓或當發生臨床上顯著的血壓上升或心跳加快可能會令病情惡化的嚴重心血管疾病病人;
  2. 對於具有會受血壓或心率增加而令病情惡化的潛在疾病, 如高血壓﹑心跳過快或心腦血管疾病的病人, 應謹慎使用atomoxetine;
  3. 對患有先天性或獲得性長QT綜合症或具有QT間期延長家族史的病人, 應謹慎使用atomoxetine;
  4. 於開始使用atomoxetine治療前, 應檢測病人已有或潛在的心腦血管疾病, 在治療的過程中也要進行監測;
  5. 建議於開始atomoxetine治療前, 對所有病人測量心跳及血壓, 當增加劑量和治療期間, 也要定期測量心跳及血壓, 特別在治療的首數個月, 以儘早發現上述臨床事件。

 

         Health Canada and Eli Lilly would like to inform health professionals about the risk of increased blood pressure and increased heart rate with the use of atomoxetine (Strattera®), a selective norepinephrine reuptake inhibitor indicated for treatment of attention deficit hyperactivity disorder (ADHD) in children and adults.  A recent analysis of combined data from Eli Lilly sponsored controlled and uncontrolled clinical trials has indicated that in pediatric patients treated with atomoxetine, approximately 25% experienced an increase in blood pressure of 10 mmHg and 5-8% an increase of 20 mmHg while heart rate increased by 10 bpm in 33% of patients and by 20 bpm in 12% of patients.  These increases could represent a risk for some patients.  Updated recommendations for physicians, pharmacists and other health professionals include:

  1. atomoxetine is contraindicated in patients with symptomatic cardiovascular diseases, moderate to severe hypertension or severe cardiovascular disorders whose condition would be expected to deteriorate if they experienced increases in blood pressure or in heart rate that could be clinically important;
  2. atomoxetine should be used with caution in patients whose underlying medical conditions could be worsened by increases in blood pressure or heart rate, such as patients with hypertension, tachycardia, or cardiovascular or cerebrovascular disease;
  3. atomoxetine should be used with caution in patients with congenital or acquired long QT syndrome or a family history of QT prolongation;
  4. patients should be screened for pre-existing or underlying cardiovascular or cerebrovascular conditions before initiation of treatment with atomoxetine and monitored during the course of treatment;
  5.  it is recommended that heart rate and blood pressure be measured in all patients before treatment with atomoxetine is started, after the dose is increased, and periodically during treatment to detect possible clinically important increases, particularly during the first few months of therapy.

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