藥物警訊

Revatio (sildenafil): Drug Safety Communication - FDA Clarifies Warning About Pediatric Use for Pulmonary Arterial Hypertension

AUDIENCE: Cardiology, Pediatrics, Pharmacy

ISSUE: FDA is clarifying its previous recommendation related to prescribing Revatio (sildenafil) for children with pulmonary arterial hypertension (PAH). Revatio is FDA-approved only to treat PAH in adults, not in children; however, health care professionals must consider whether the benefits of treatment with the drug are likely to outweigh its potential risks for each patient.

FDA revised the Revatio drug label in August 2012, adding a warning stating that “use of Revatio, particularly chronic use, is not recommended in children.” This recommendation was based on an observation of increasing mortality with increasing Revatio doses in a long-term clinical trial in pediatric patients with PAH. FDA issued a Drug Safety Communication at that time. There may be situations in which the benefit-risk profile of Revatio may be acceptable in individual children, for example, when other treatment options are limited and Revatio can be used with close monitoring.

BACKGROUND: The purpose of the August 2012 recommendation was to raise awareness of clinical trial results showing a higher risk of mortality in pediatric patients taking a high dose of Revatio when compared to pediatric patients taking a low dose. This recommendation was not intended to suggest that Revatio should never be used in children; however, some health care professionals have interpreted this information as a contraindication, and have refused to prescribe or administer the drug.

RECOMMENDATION: The evidence behind FDAs initial recommendation has not changed; this communication is clarifying the strength of the warning communicated in the Revatio drug label.

Read the MedWatch safety alert, including links to the Drug Safety Communication and prescribing information, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

美國FDA再次說明有關2012年發布之Revatio (sildenafil)用於兒童肺動脈高壓(PAH)建議。Revatio為FDA核可用於成人之肺動脈高壓(PAH)治療，兒童尚未核准使用。FDA提醒醫療人員應依病人臨床狀況並權衡利弊，再開立處方。

FDA曾於2012年8月修訂Revatio之藥品仿單，新增有關“兒童不建議使用Revatio，由其是經評估須長期使用之兒童”之警語。此建議為依據一件有關肺動脈高壓(PAH)之小兒病人進行長期性的臨床試驗結果，當Revatio的劑量增加，死亡率也隨之增加。當時FDA立即發布藥物安全警訊，說明若經個別評估病人使用Revatio之利大於弊則可使用，如當其他選擇無效時，Revatio可在密集監測下使用。

FDA於2012年8月發布之藥物安全警訊目的為提高醫療人員對於此臨床試驗結果的注意，並非表示兒童不能使用此藥，然而部分醫療人員將其解釋為兒童使用禁忌，且拒絕開立或給藥。

FDA特此告知，此則藥物安全通訊為釐清藥品仿單上之警語涵意。因目前未有更新之證據，FDA仍維持原先的用藥建議。

相關訊息與連結請參考FDA網址：

http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHuma...

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