Actelion Pharmaceuticals US, Inc. Floods FDA With Patient Death Reports

Two years ago, the FDA inspected Actelion Pharmaceuticals offices and found the drugmaker failed to follow proper procedures for reporting adverse events and, as a result, about 3,500 patient deaths were never filed with the agency. A follow-up warning letter was issued and, in response, Actelion went to the other extreme - every adverse event mentioning ‘death’ was effectively dumped with the FDA, regardless of whether there was a reasonable likelihood that its drug was involved. How many reports are we talking about? A mere 4,133 for its Tracleer med, which is used to treat pulmonary aterial hypertension, and they went back five years.

Back to news