藥物警訊（藥師週刊 第1733期）

AUDIENCE: Risk Manager, Pharmacy, Patients

Ortho-McNeil Neurologics Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc., is recalling two lots of Topamax (topiramate) 100mg Tablets. The recall stems from four consumer reports of an uncharacteristic odor thought to be caused by trace amounts of TBA (2,4,6 tribromoanisole). While not considered to be toxic, TBA can generate an offensive odor and a small number of patients have reported temporary gastrointestinal symptoms. There have been no reported serious adverse events caused by the presence of TBA in Topamax.

BACKGROUND: Topamax is indicated as initial monotherapy in patients 10 years of age and older with partial onset or primary generalized tonic-clonic seizures; as adjunctive therapy for adults and pediatric patients ages 2 ? 16 years with partial onset seizures, or primary generalized tonic-clonic seizures, and in patients 2 years of age and older with seizures associated with Lennox-Gastaut syndrome; and for adults for the prophylaxis of migraine headache.

RECOMMENDATION: Patients taking Topamax 100mg Tablets who experience an uncharacteristic odor associated with their medication should return the tablets to their pharmacist, and contact their healthcare professional if they have questions.

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 MedWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

因為有四名使用者回報Topamax 100 mg錠劑有異味，所以嬌生製藥公司回收2批藥品；異味可能是因為微量成分TBA (2,4,6 tribromoanisole)所造成的，並不會造成毒性，使用後有少數的病人出現短暫的腸胃症狀，但並無嚴重的不良反應案例。

Topamax用於10歲以上病人局部或原發性全身性強直陣攣癲癇之單一藥物治療；成人及兩歲以上兒童局部癲癇或併有LENNOX-GASTAUT症候群之癲癇及原發性全身性強直陣攣癲癇的輔助治療；成人預防偏頭痛。

建議病人服用到有異味的Topamax 100 mg錠劑時，應將藥品退回給藥師並如有任何問題請聯繫醫療人員。

相關訊息與連結請參考FDA網址：Read the MedWatch safety alert, including a link to the Press Release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm251556.htm
[Posted 04/15/2011]

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