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 […]
August 13th, 2012
Universal Screening for Dyslipidemia in Children: A Debate with Equipoise, but Tarnished by Industry Influence
William O Roberts, MD, MS
James H. Stein, MD sounds a clarion about the influence of the medical industry on the debate over whether children should be universally screened for dyslipidemia, as recommended by recent guidelines.
July 2nd, 2012
Eroding Confidence in ASD Occlusion Devices
Richard A. Lange, MD, MBA and L. David Hillis, MD
The FDA has identified more than 100 cases of cardiac erosion following atrial septal defect occlusion (ASO) device implantation. All were associated with implantation of the AMPLATZER (AGA Medical/St. Jude Medical) or related cribriform ASO devices; none have been reported thus far with the GORE HELEX (Gore Medical) ASO device. Although the estimated occurrence of cardiac erosion […]