In a Sept. 14 warning letter, the FDA said Actelion Pharmaceuticals US Inc. failed to report about 3,500 patient deaths in connection with Tracleer and Ventavis--which are drugs approved to treat pulmonary arterial hypertension--"without an adequate basis for not reporting them." The letter was posted on the FDA's website Tuesday.
The FDA said that it wasn't concluding that the deaths were linked to the drugs, but that Actelion didn't follow proper procedures in determining if the deaths should be reported to the FDA and under which procedure.
In cases where a drug might play a role in a patient death, or in cases where companies don't have enough information to determine if a drug might have contributed, deaths must be reported to the FDA within 15 days. In other cases, deaths and side effects can be reported in annual periodic safety updates if information suggests the death is not drug-related.
"Actelion is responsible for ensuring that it has a system in place to keep FDA appropriately apprised of adverse events so that FDA can appropriately evaluate the safety of drugs in the post-market environment," the agency said.
An Actelion spokesman said the company was working with the FDA to resolve the matters raised in the letter.
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