1517期    2007-4-9至20067-4-15    發行人:何榮生     社    長:連瑞猛     總編輯:劉新華     主    編:張玉明     記    者:蔡秋鳳     藥物警訊 Ketek (telithromycin) 賽諾菲安萬特藥廠通知醫療專業人員，提醒大家Ketek（telithromycin）的標示已經修改，增加了加框警語與增列患有重症肌無力的病患為使用此藥品的禁忌。此外，標示已除去Ketek用於治療慢性支氣管炎的急性惡化(acute bacterial exacerbations of chronic bronchitis)和急性細菌性鼻竇炎(acute bacterial sinusitis) 此二種適應症。重要的是在開立KETEK時，醫療專業人員必須告知病患並與病患討論以下四個需要注意的毒性:使重症肌無力患者病情加劇、肝毒性、意識不清與視線模糊。 為了更有效的告知與教育病患，已製作KETEK病患用藥指引，並更新到美國的處方資訊中KETEK的病患用藥資訊章節。當藥師調劑KETEK時必須同時提供病患用藥指引，同時醫療專業人員必須請病人在服用KETEK前先閱讀病患用藥指引。 FDA and Sanofi-Aventis notified healthcare professionals of revisions to the prescribing information, including a BOXED WARNING and a new Patient Medication Guide, for the antibiotic Ketek. Two of the three previously approved indications, acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis, were removed from the prescribing information because the balance of benefits and risks no longer support approval of the drug for these indications. Ketek will remain on the market for the treatment of community acquired pneumonia of mild to moderate severity. In addition, warnings were strengthened for hepatotoxicity (liver injury), loss of consciousness, and visual disturbances. The BOXED WARNING states that Ketek is contraindicated in patients with myasthenia gravis. The Patient Medication Guide, which must be distributed to all patients, informs them about the risks of the drug and how to use it safely. [UPDATE 03/26/2007] 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