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10/6/2011 7:50:51 AM
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.
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