BETHESDA, MD 27 February 2013—The recent death of a 14-year-old patient in a clinical trial prompted FDA to suspend all pediatric studies of cinacalcet hydrochloride, the agency announced February 26.
According to FDA, the agency is evaluating information about the situation and has not yet determined whether the drug contributed to the teen's death.
The federal clinical trials website lists four ongoing pediatric studies of cinacalcet, three of them sponsored by Amgen, which sells the drug under the brand name Sensipar. The fourth ongoing study is sponsored by a researcher in Italy. Information about a fifth clinical trial was last updated in 2005, and that study has an "unknown" status.
Cinacalcet, a calcium-sensing receptor agonist, is indicated for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease undergoing dialysis; severe HPT in patients who cannot undergo parathyroidectomy; and hypercalcemia in patients with parathyroid carcinoma.
The labeling (PDF) for Sensipar states that the drug's safety and efficacy have not been established in pediatric patients. But the indications do not explicitly state that the drug is for use only in adults.
FDA stated that the agency "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."
FDA advised clinicians to be aware that cinacalcet lowers blood calcium concentrations. Clinicians should monitor patients for hypocalcemia during treatment with the drug and take appropriate steps to increase abnormally low calcium levels.
According to the agency, a patient's serum calcium level should be measured within one week of starting cinacalcet therapy and after any dosage adjustment. Monthly testing is recommended once the patient is established on a maintenance dosage of the drug.