Voluntary withdrawal of the drug aprotinin from the US market in 2008 has increased the risk of bleeding in babies and young children after reconstructive cardiac surgery. The data on which the Bayer Corporation and FDA based their decision to withdraw the drug were obtained entirely from adults who are at risk of a different profile of complications following cardiac surgery than children. Furthermore, serious questions have been raised regarding the initial widely publicized article which questioned the safety of aprotinin. Some believe that the article was a misapplication of the new statistical method of propensity scoring. The fact that the principal author has not allowed free access to the raw data has raised further questions. Aprotinin is no longer under patent protection and could be evaluated under the pediatric exclusivity provision. It presents an excellent opportunity for alternative suppliers to undertake a clinical trial in a pediatric population of heart surgery patients.
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