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Gilenya (fingolimod): Drug Safety Communication - Safety Review of a Reported Death After the First Dose
AUDIENCE: Neurology, Patients
ISSUE: The FDA has received a report of a patient with multiple sclerosis (MS) who died within 24 hours of taking the first dose of Gilenya (fingolimod). At this time, FDA cannot conclude whether the drug resulted in the patient's death. FDA is continuing to evaluate the case and will communicate any new information that results from this investigation.
BACKGROUND: Gilenya (fingolimod) is an oral medication for the treatment of relapsing forms of Multiple Sclerosis (MS) in adults. Gilenya is used to reduce the frequency of flare-ups (clinical exacerbations) and delay physical disability.
RECOMMENDATION: At this time, FDA continues to believe that Gilenya provides an important health benefit when used as directed and recommends that healthcare professionals who prescribe Gilenya follow the recommendations in the approved drug label. Patients with MS should not stop taking Gilenya without talking to their healthcare professional.
FDA will communicate any new information on Gilenya and this case when it becomes available.
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 Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
FDA接獲多發性硬化症(multiple sclerosis, MS)病人在服用第一劑Gilenya (fingolimod)24小時內死亡的通報。此時，FDA還不能確認該病人死亡是否與藥品相關，但是將會持續評估此案例，並會在有進一步資訊時公告大 眾。
Glienya (fingolimod)是一種治療成人反覆發作型MS的口服藥，可降低復發的頻率(臨床惡化)並延緩病人生理障礙。
此時，FDA認為依據藥品仿單資訊使用Gilenya仍具有其重要之臨床效益，並建議正在服用的病人不要擅自停藥。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm284355.htm
[Posted 12/20/2011]
Liquid Acetaminophen marketed for infants: Drug Safety Communication - Potential for Dosing Errors
AUDIENCE: Pediatrics, Consumers, Pharmacy
ISSUE: The FDA is informing the public that an additional concentration of liquid acetaminophen marketed for “infants” (160 mg/5 mL) is now available. This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen.
BACKGROUND: Over-the-Counter (OTC) Liquid acetaminophen is used to temporarily reduce fever and relieve minor aches and pains due to the common cold, flu, headache, minor sore throat, and toothache. Acetaminophen is marketed under brand names such as Tylenol, Little Fevers, Triaminic, Infant/Pain Reliever, Pedia Care, Triaminic Infants’ Syrup Fever Reducer Pain Reliever and other store brands (e.g., Rite Aid, CVS, Walgreens brand, etc.).
This change in the concentration will affect the amount of liquid given to an infant, and should be especially noted if someone is accustomed to using the 80 mg /0.8 mL or 80 mg/mL concentrations of liquid acetaminophen. In addition to this change in concentration, this product may also be packaged with an oral syringe instead of a dropper.
RECOMMENDATION: Read the Drug Facts label on the package to identify the concentration of the liquid acetaminophen (in mg/mL), dosage, and directions for use.
Use the dosing device provided with the product in order to correctly measure the amount of liquid acetaminophen to be given. Healthcare professionals should provide directions to patients that specify the concentration and dose of liquid acetaminophen that should be given to a child.
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 company press release, at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm284807.htm
FDA公告大眾，目前有新濃度(160 mg/5 mL)的acetaminophen液劑上市，因為藥品是新濃度，所以會影響給藥的體積，對於習慣使用80 mg/0.8 mL或80 mg/mL acetaminophen液劑的人須特別注意。除了濃度上的改變，包裝所附之器具也從滴管改成口服針筒。
非處方藥(Over-the-Counter, OTC) acetaminophen液劑被用於暫時緩解發燒及因為感冒、流感、頭痛、喉嚨痛或牙痛引起之輕微疼痛。Acetaminophen上市的藥品名稱有 Tylenol、Little Fevers、Triaminic、 Infant/Pain Reliever、Pedia Care、Triaminic Infants’ Syrup Fever Reducer Pain Reliever 及其他廠牌(如 Rite Aid、CVS、Walgreens brand等)。
建議在使用藥品前詳細閱讀仿單，以確認濃度、劑量及使用指示；並使用包裝所附之給藥器具正確量取所需劑量。也建議醫療人員應衛教病人所使用藥品的濃度與劑量。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm284807.htm
[Posted 12/22/2011]
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
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資料來源：藥師週刊（第1761期）