藥物警訊

Nizoral (ketoconazole): Drug Safety Communication - Potentially Fatal Liver Injury, Risk of Drug Interactions and Adrenal Gland Problems
 

AUDIENCE: Internal Medicine, Infectious Disease

ISSUE: FDA is taking several actions related to Nizoral (ketoconazole) oral tablets, including limiting the drug’s use, warning that it can cause severe liver injuries and adrenal gland problems, and advising that it can lead to harmful drug interactions with other medications. FDA has approved label changes and added a new Medication Guide to address these safety issues. As a result, Nizoral oral tablets should not be a first-line treatment for any fungal infection. Nizoral should be used for the treatment of certain fungal infections, known as endemic mycoses, only when alternative antifungal therapies are not available or tolerated.

Liver Injury (Hepatotoxicity)

Nizoral tablets can cause liver injury, which may potentially result in liver transplantation or death. FDA has revised the Boxed Warning, added a strong recommendation against its use (contraindication) in patients with liver disease, and included new recommendations for assessing and monitoring patients for liver toxicity.

Adrenal Insufficiency

Nizoral tablets may cause adrenal insufficiency by decreasing the body's production of corticosteroids.

Drug Interactions

Nizoral tablets may interact with other drugs a patient is taking and can result in serious and potentially life-threatening outcomes, such as heart rhythm problems.

See the FDA Drug Safety Communication for additional information, including a Data Summary.

BACKGROUND: Nizoral (ketoconazole) is indicated for the treatment of fungal infections when alternatives are not available or not tolerated. The topical formulations of Nizoral have not been associated with liver damage, adrenal problems, or drug interactions. These formulations include creams, shampoos, foams, and gels applied to the skin, unlike the Nizoral tablets, which are taken by mouth.

RECOMMENDATION: Nizoral tablets should be used only for the treatment of certain life-threatening mycoses when the potential benefits outweigh the risks and alternative therapeutic options are not available or tolerated. Healthcare professionals should assess the liver status of the patient before starting oral ketoconazole, and monitor serum ALT levels during treatment. Adrenal function should be monitored in patients with adrenal insufficiency or with borderline adrenal function and in patients under prolonged periods of stress (major surgery, intensive care, etc.). Review all concomitant medications for the potential for drug interactions with Nizoral tablets.

Read the MedWatch safety alert, including links to the Drug Safety Communication and label, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA發布Nizoral (ketoconazole)口服錠藥物安全警訊，此藥可能造成嚴重肝臟損害和影響腎上腺功能，並可能與其他藥物產生具傷害性之交互作用。美國FDA已核准仿單變更，且增加新的用藥指示，以提醒注意此問題。Nizoral 口服錠不應作為任何黴菌感染之第一線治療用藥，其可用於其他抗黴菌藥物治療無效或耐受性不佳的特定黴菌感染，如endemic mycoses。

肝臟損害（肝毒性）

Nizoral 口服錠可能會引起肝臟損傷，進而導致肝臟移植或死亡。FDA建議此藥不可用於有肝臟疾病的病人，且須定期評估與監測是否產生肝毒性。

腎上腺功能不全

Nizoral 口服錠可能會減少體內皮質類固醇的生成，而導致腎上腺皮質功能不全。

藥物交互作用

Nizoral 口服錠可能會與其他藥品產生嚴重、具潛在致命性的交互作用，如心臟節律問題。

建議：

Nizoral (ketoconazole) 的適應症為用於當其他藥物無效或耐受性不佳之黴菌感染。此成分之外用製劑如乳膏、洗髮劑、泡沫劑，與凝膠並不會產生以上問題。

Nizoral (ketoconazole) 應限用於當評估其可能的效益大於風險、對其他治療無耐受性、且為危及生命的黴菌感染。在給予口服ketoconazole前，醫療人員應評估病人肝功能，並於治療期間監測血中ALT。當病人腎上腺皮質功能不全或介於正常值邊緣，或長期處在壓力下(如重大手術，重症)，應檢測腎上腺皮質功能。
 

相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm362672.htm
[Posted 07/26/2013]

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