Tracleer bosentan regulatory update

FDA issued a warning letter to Actelion after an inspection revealed that the company failed to comply with postmarketing safety reporting requirements for 3 drugs. FDA said the company failed to report serious and unexpected adverse events within the required 15 days after initial receipt of the information for pulmonary arterial hypertension (PAH) drugs Tracleer bosentan and Ventavis iloprost, and Gaucher's disease therapy Zavesca miglustat. The letter noted that Actelion failed to report about 3,500 patient deaths in connection with Tracleer and Ventavis, without an adequate basis for not reporting them.

FDA acknowledged that PAH is a serious condition that often results in patient deaths and said that by issuing the letter it has not concluded that Tracleer and Ventavis caused the deaths. FDA requested the company notify the agency within 15 days of specific steps to correct the violations and to prevent recurrence. The agency said failure to promptly correct the deviations would result in regulatory action, including injunction and prosecution. Actelion said it is working with FDA to resolve the issues. ...