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US FDA warns Actelion for misleading Tracleer flash card

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Executive Summary

A flash card used by Actelion Pharmaceuticals sales reps which makes a direct comparison between the company's pulmonary arterial hypertension treatment Tracleer (bosentan) and sildenafil (Pfizer's Revatio) is misleading because it presents an unsubstantiated superiority claim and omits serious and important risk information associated with the use of Tracleer, the US FDAsays in a warning letter. The promotion focused on four considerations a practitioner might use when selecting a therapy for PAH, but the agency said the four questions asked could not be used to support the superiority of Tracleer. Additionally, the promotion omitted material information on Tracleer's serious risks "that are highly relevant to any decision about whether to prescribe Tracleer or sidenafil", the agency wrote. Tracleer is approved under a risk management programme (including restricted distribution) and has a boxed warning due to the risks of potential liver injury and major birth defects – restrictions and warnings which are not part of the sildenafil product label. The FDA requests that Actelion submit a corrective messaging plan; Actelion has stated that it intends to fully comply with the agency's request.

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