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.
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 the clinical trials were underway to determine if the drug is effective and can be used safely in children.
RECOMMENDATION: At this time, FDA would like to remind health care professionals of the following:
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
[02/26/2013 - Drug Safety Communication - FDA]