Cinacalcet hydrochloride (Sensipar)
March 5, 2013
FDA stopped all clinical trials of cinacalcet hydrochloride (Sensipar) in pediatric patients following the death of a 14-year-old trial participant. FDA has not determined if the patient’s death was medication related. FDA is continuing to investigate the circumstances surrounding the situation. These clinical trials were being conducted to evaluate the safety and effectiveness of cinacalcet in pediatric patients younger than 18 years of age.
Cinacalcet is a calcium-sensing receptor agonist labeled to treat primary hyperparathyroidism in patients who are unable to undergo a parathyroidectomy, secondary hyperparathyroidism in dialysis patients with chronic kidney disease, and parathyroid cancer. Cinacalcet is approved for use in adults only. This medication decreases the release of parathyroid hormone from the parathyroid gland resulting in a decrease in serum calcium concentrations. Low calcium concentrations result in health problems including convulsions, muscle cramps, myalgias, paresthesias, and tetany. In adult clinical trials, the most frequently reported side effects of the medication included nausea, vomiting, and diarrhea.
Monitor serum calcium concentrations within one week of starting cinacalcet or adjusting the dose. Continue to monitor calcium concentrations monthly after a maintenance dose is established. Options to correct low serum calcium concentrations include the following:
- Temporarily discontinue use of cinacalcet
- Provide supplemental calcium
- Start or increase the dose of vitamin D sterols
- Start or increase dose of a calcium-based phosphate binder
Report any drug-related adverse events to FDA’s MedWatch adverse events reporting program online at www.fda.gov/MedWatch/report.htm, by phone at 1-800-332-1088, by fax at 1-800-FDA-0178, or by mailing the completed form found at http://www.fda.gov/downloads/Safety/MedWatch/DowloadForms/UCM082725.pdf.
Additional information is available at the following links:
- FDA alert:
- Drug Safety Communication:
March 5, 2013; University of Utah, Drug information Service. Copyright 2013, Drug Information Service, University of Utah, Salt Lake City, UT.