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Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death
AUDIENCE: Health Professional, Endocrinology, Pediatrics
ISSUE: FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial.? Posting this information does not mean that FDA has concluded whether or not Sensipar had a role in the patient’s death. This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete.
BACKGROUND: Sensipar is a calcium-sensing receptor agonist indicated in adults for secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, hypercalcemia in patients with parathyroid cancer and severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy.? FDA has approved Sensipar for use in adults but not in children (less than 18 years of age), and the clinical trials were underway to determine if the drug is effective and can be used safely in children.
RECOMMENDATION: At this time, FDA would like to remind health care professionals of the following:
‧ Patients should be monitored for the development of low serum calcium levels (hypocalcemia) since Sensipar lowers calcium levels in the blood.?
‧ The potential signs of low serum calcium levels include muscular problems such as muscle cramping, tetany, convulsions, paresthesias, and myalgias.
‧ If serum calcium levels decrease below the normal range, appropriate steps should be taken to increase calcium levels, such as by providing supplemental calcium, initiating or increasing the dose of a calcium-based phosphate binder, initiating or increasing the dose of vitamin D sterols, or temporarily withholding treatment with Sensipar.
‧ Serum calcium levels should be measured within 1 week after initiation or dose adjustment of Sensipar.? Once a maintenance dose has been established, serum calcium should be measured monthly.
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, including a link to the Drug Safety Communication, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...
近日因一名參與Sensipar (cinacalcet hydrochloride)試驗之14歲病人死亡，FDA停止所有sensipar之兒童臨床試驗。此資訊之發布不代表FDA已確定此病人之死因與 sensipar相關，其目的為告知醫療人員，FDA正對此訊息進行評估，待審查結束後將會傳達最後結論與建議。
Sensipar為鈣敏感受體致效劑，可用於患有續發性副甲狀腺機能亢進與慢性腎衰竭正進行血液透析之成年病人、患有副甲狀腺癌之高血鈣病人、以及無法接 受副甲狀腺切除手術之原發性副甲狀腺亢進的嚴重高血鈣病人。FDA目前核准Sensipar於18歲以上之成人使用，兒童臨床試驗正在進行中，以確定此藥 用於兒童是否安全且有效。
FDA提醒醫療專業人員以下注意事項：
1. Sensipar會降低血中鈣離子濃度，服用此藥之病人應監測其血鈣濃度之變化。
2. 應注意低血鈣之潛在性症狀，包含肌肉問題，例如肌肉痙攣、手足抽搐、感覺異常、肌肉疼痛。
3. 若血鈣濃度低於正常範圍，應採取適當措施增加血鈣濃度，像是提供鈣質補充劑、增加鈣磷結合劑之劑量，開始使用或增加維生素D之攝取，或暫時停止服用Sensipar。
4. 初次服用或有做劑量調整之病人應於一星期內監測血鈣濃度。一旦開始服用維持劑量，應每月監測。
相關訊息與連結請參考FDA網址：http://www.fda.gov/Safety/MedWatch/SafetyInformation /SafetyAlertsforHumanMedicalProducts/ucm341255.htm
[Posted 02/26/2013]
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
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資料來源：藥師週刊（第1814期）