September 4th, 2012
FDA Warns Against Using Revatio in Kids with Pulmonary Hypertension
Revatio (sildenafil) should not be prescribed to children and adolescents with pulmonary arterial hypertension, according to an FDA MedWatch alert.
The warning is based on the results of a trial published in Circulation that showed increased mortality at medium and high doses of Revatio, compared with low-dose treatment, among patients aged 1 to 17 years. Low-dose Revatio did not improve exercise capacity.
The FDA notes that Revatio has never been approved to treat pulmonary arterial hypertension in children.
Reprinted with permission from Physician’s First Watch