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Sprycel (dasatinib): Drug Safety Communication - Risk of Pulmonary Arterial Hypertension

AUDIENCE: Hematology, Oncology

ISSUE: FDA notified healthcare professionals that Sprycel (dasatinib) may increase the risk of a rare but serious condition in which there is abnormally high blood pressure in the arteries of the lungs (pulmonary arterial hypertension [PAH]). Symptoms of PAH may include shortness of breath, fatigue, and swelling of the body (such as the ankles and legs). In reported cases, patients developed PAH after starting Sprycel, including after more than one year of treatment.

Information about this risk has been added to the Warnings and Precautions section of the Sprycel drug label.

BACKGROUND: Sprycel (dasatinib) is used to treat certain adult patients with Philadelphia chromosome-positive chronic myeloid leukemia (CML) or acute lymphoblastic leukemia (ALL).

RECOMMENDATION: Healthcare professionals should evaluate patients for signs and symptoms of underlying cardiopulmonary disease prior to starting Sprycel and also during treatment. If PAH is confirmed, Sprycel should be permanently discontinued.

Read the Drug Safety Communication for additional information including a data summary.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

* Complete and submit the report Online:

* Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch safety alert, including a link to the Drug Safety Communication, at:

FDA提醒醫護人員,Sprycel (dasatinib) 可能會增加罕見但嚴重肺動脈高壓(pulmonary arterial hypertension [PAH])的風險;PAH的症狀可能包括呼吸短促、疲倦及身體水腫( 如腳踝和腿)。在回報的案例中,包括病人在服用Sprycel 超過一年後才發生PAH。此項風險已增加至Sprycel 仿單中警示與注意事項的部份。

Sprycel (dasatinib) 被用來治療成人罹患Piladelphia chromosome-positive chronic myeloid leukemia (CML) 或acute lymphoblastic leukemia (ALL)。

建議在病人接受Spr y cel 治療前及治療中,醫護人員應評估病人潛在心肺疾病的症狀;如果PAH的診斷被確認,應永久停止使用Sprycel。

相關訊息與連結請參考FDA 網址:

[Posted 10/11/2011]