藥物警訊（藥師週刊 第1729期）

Revlimid (lenalidomide): Ongoing Safety Review - increased risk of developing new malignancies

AUDIENCE: Hematology, Oncology

ISSUE: [Posted 04/08/2011]FDA is informing the public that we?are aware of results from clinical trials conducted inside and outside the United States that found that patients treated with Revlimid (lenalidomide) may be at an?increased risk of developing new types of cancer compared to patients who did not? take the drug.FDA is currently reviewing all available information on this potential?risk and will communicate any new recommendations once it has completed its review.

BACKGROUND: Revlimid is used to treat a type of blood disorder known as myelodysplastic syndrome. Revlimid is also used along with other drugs to treat people with the cancer known as multiple myeloma.

RECOMMENDATION: At this time, there is no recommendation to delay, modify or restrict the use of Revlimid for patients being treated according to the FDA-approved indications. FDA is currently reviewing all available information. on this potential risks and will communicate any new recommendations once it has completed its review.

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: www.fda.gov/MedWatch/report.htm
* 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 complete MedWatch Safety?Alert at:?http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm250606.htm

FDA根據美國境內與境外的臨床試驗結果，發現Revlimid (lenalidomide)可能會讓使用者增加形成新的癌症的風險。FDA目前正在檢視所有的資訊，當檢視完畢後將會提出新的建議。Revlimid可 治療一種名為骨髓化生不良症候群(myelodysplastic syndrome)的血液疾病，也可與其他藥物併用來治療多發性骨髓瘤(multiple myeloma)。

目前對於使用Revlimid的病人，FDA還沒有提出需要改變治療方式的建議，FDA目前正在檢視所有的資訊，當檢視完畢後將會提出新的建議。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm250606.htm
[Posted 04/08/2011]

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