Actelion Pharma Failed To Report 3,500 Deaths

During an inspection of Actelion Pharmaceuticals which took place in the summer of 2009, the FDA found the drugmaker failed to report about 3,500 patient deaths. The patients were taking the drugs Tracleer or Ventavis, which are used to treat pulmonary arterial hypertension.

Federal law requires that deaths be reported “when there is a reasonable possibility that the drug caused the death.” Actelion had no information regarding whether its drugs led to the deaths, and so should have filed reports.

The FDA, according to Pharmalot, said that:

“Actelion presumes that there is no relationship between the two and does not report the death to FDA on an expedited basis. That is not an acceptable basis for such a conclusion ... Reports of death always are considered serious and, for both Tracleer and Ventavis, would also be considered unexpected as death is not identified as an adverse event in the product labeling.”

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