The FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet HCl; Amgen) after a recent death of a 14-year-old patient in a trial. It has not been concluded whether Sensipar had a role in the patient’s death. The information is being further evaluated by the FDA.
Sensipar is a calcimimetic 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.
The FDA is recommending healthcare professionals to monitor patients for the development of hypocalcemia. Signs may include muscle cramping, tetany, convulsions, paresthesias, and myalgias. Calcium supplementation and adjusting calcium-based phosphate binders, vitamin D sterols, or temporary withholding of Sensipar may be necessary. Serum calcium levels should be measured within one week after initiation or dose adjustment and then monthly thereafter.
For more information call (800) 332-1088 or visit http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm341255.htm