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Revatio (sildenafil): Drug Safety Communication - Recommendation Against Use in Children


AUDIENCE: Pediatrics, Cardiology, Pulmonology

ISSUE: FDA notified healthcare professionals and their medical care organizations that Revatio (sildenafil) should not be prescribed to children (ages 1 through 17) for pulmonary arterial hypertension (PAH).This recommendation against use is based on a recent long-term clinical pediatric trial showing that: (1) children taking a high dose of Revatio had a higher risk of death than children taking a low dose and (2) the low doses of Revatio are not effective in improving exercise ability. Treatment of PAH in children with this drug is an off-label use (not approved by FDA) and a new warning, stating the use of Revatio is not recommended in pediatric patients has been added to the Revatio labeling.

BACKGROUND: Revatio is a phosphodiesterase-5 inhibitor used to treat pulmonary arterial hypertension by relaxing the blood vessels in the lungs to reduce blood pressure and is approved to improve exercise ability and delay clinical worsening of PAH in adult patients (WHO Group I).

RECOMMENDATION: Patients and caregivers are advised to not change the Revatio dose or stop taking Revatio without talking to a health care professional. Healthcare professionals were reminded that use of this product, particularly chronic use, in children is an off-label indication, not approved by FDA, and is not recommended. See the Drug Safety Communication for the Data Summary from the randomized, double-blind, placebo-controlled clinical trial of 234 patients with PAH, 1 to 17 years of age with mild to moderate symptoms at baseline.

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

FDA告知醫療專業人員及醫療保健機構,Revatio (sildenafil)不應用來治療一至十七歲兒童的肺動脈高壓(PAH)。依據最近的長期性兒童臨床試驗結果顯示:(1)兒童服用高劑量之 Revatio比服用低劑量具有較高的死亡風險。(2)低劑量的Revatio無法有效的提高運動能力。

Revatio仿單已註明Revatio用於兒童為核准適應症以外的用法 (off-label use,FDA未核准) 及Revatio不建議用於病童的新警語。

Revatio為phosphodiesterase-5 inhibitor,利用其可放鬆肺部血管進而降低血壓之機轉來治療肺動脈高壓,在成年的肺動脈高壓病人已證實可用來改善運動能力跟延緩臨床上的疾病惡化 (WHO Group I)。


相關訊息與連結請參考FDA網址: /SafetyAlertsforHumanMedicalProducts/ucm317743.htm
[Posted 08/30/2012]