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FDA Medwatch Alert: Sensipar (Cinacalcet Hydrochloride): Drug Safety Communication - FDA Suspends Pediatric Clinical Trials After Report Of Death
Posted 26 Feb 2013 by Drugs.com
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. BACKGROUND: Sensipar is a calcium-sensing receptor agonist indicated in adults for secondary hyperparathyroidism in patients with chronic kidney disease on dialysis, hypercalcemia in patients with parathyroid cancer and severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy. FDA has approved Sensipar for use in adults but not in children (less than 18 years of age), and ... Read more