FDA, 14 yaşındaki hastanın ölümünün ardından Sensipar’ın pediyatrik klinik çalışmalarını askıya aldı (İng)


Drug Safety Communication: Sensipar (Cinacalcet Hydrochloride) – FDA Suspends Pediatric Clinical Trials After Report Of Death

February 26, 2013

Audience: Health Professional, Endocrinology, Pediatrics.

ISSUE: FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial.  Posting this information does not mean that FDA has concluded whether or not Sensipar had a role in the patient’s death. This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete.