FDA warns against use of Pfizer's Revatio in children with PAH

2 September 2012

The US Food and Drug Administration is recommending that Revatio (sildenafil), marketed by US drugs behemoth Pfizer (NYSE: PFE) should not be prescribed to children (ages one 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 those taking a low dose; and (2) the low doses of Revatio are not effective in improving exercise ability. Most deaths were caused by pulmonary hypertension and heart failure, which are the most common causes of death in children with PAH.

Facts about sildenafil

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