藥物警訊

Zecuity (sumatriptan) Migraine Patch: Drug Safety Communication - FDA Evaluating Risk of Burns and Scars

UPDATED 06/13/2016:Zecuity manufacturer Teva Pharmaceuticals has decided to temporarily suspend sales, marketing, and distribution to investigate the cause of burns and scars associated with the Zecuity patch. Health care professionals should discontinue prescribing Zecuity, and patients should stop using any remaining patches and contact their prescribers for an alternative migraine medicine. Please refer to the Dear Health Care Provider letter and the updated Drug Safety Communication for more information.

AUDIENCE: Internal Medicine, Pain Management, Neurology, Pharmacy

ISSUE: FDA is investigating the risk of serious burns and potential permanent scarring with the use of Zecuity (sumatriptaniontophoretic transdermal system) patch for migraine headaches. Since marketing of the Zecuity patch began in September 2015, a large number of patients have reported they experienced burns or scars on the skin where the patch was worn. The reports included descriptions of severe redness, pain, skin discoloration, blistering, and cracked skin. As a result, FDA is investigating these serious adverse events to determine whether future regulatory action is needed, and will update the public with new information when the FDA review is complete.

BACKGROUND: The Zecuity patch contains the active ingredient sumatriptan, a prescription medicine used to treat acute migraine headaches in adults. The patch delivery system is designed to deliver a dose of medicine by way of a single-use, battery-powered patch that is wrapped around the upper arm or thigh. It should remain in place for no longer than four hours.

RECOMMENDATION: Patients who experience moderate to severe pain at the Zecuity patch site should immediately remove it to avoid possible burns or scarring, regardless of how long the patch has been worn, and contact your health care professional. Do not bathe, shower, or swim while wearing the patch. Read the Patient Information leaflet and the Instructions for Use section in the drug label, and talk with your health care professional if you have any questions or concerns.

Health care professionals should advise patients who complain of moderate to severe pain at the application site to remove the Zecuity patch immediately. Consider a different formulation of sumatriptan or switch these patients to an alternative migraine medicine. Evaluate patients and the application site as needed.

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

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm504736.htm

美國FDA發布藥物安全警訊，有關偏頭痛用藥Zecuity貼片(sumatriptaniontophoretic transdermal system)之嚴重燒燙傷且產生永久性傷疤風險。Zecuity貼片自2015年9月上市以來，已接獲多起使用後皮膚燙傷或傷疤之通報案例，通報之症狀有嚴重紅腫、疼痛、皮膚變色、起泡及龜裂。此副作用是否需進一步處置，尚待美國FDA之調查結束後公告。

Zecuity貼片含有活性成份sumatriptan，為用於治療成人急性偏頭痛之處方用藥。此藥劑型設計為單次使用之儲藥型貼片，黏貼於上手臂或大腿處。每片使用時間不超過4小時。

美國FDA建議病人若於使用貼片時出現中重度疼痛現象，請立即取下並就醫。在用藥期間，請勿泡澡、淋浴或游泳，且應詳細閱讀相關藥品使用說明書，如有任何問題應與醫療人員連絡。

醫療人員若發現病人使用貼片之部位出現中重度疼痛情況時應立即移除，並考慮改使用其他劑型之sumatriptan藥品或換其他用藥。

2016年6月13日更新：廠商宣布將暫停銷售Zecuity貼片。請醫療人員停止處方此藥，目前正使用此藥之病人應立即停用並與醫療人員連絡更改用藥。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm504736.htm

[Posted 06/13/2016]

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