The FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) after the recent death of a 14-year-old patient in a trial. The FDA continues to gather information on the circumstances surrounding the patient’s death. The FDA approved Sensipar for use in adults but not in children (less than 18 years of age). The clinical trials were underway to determine if the drug is effective and can be used safely in children.
Sensipar is a calcium-sensing receptor agonist indicated in adults for the treatment of secondary hyperparathyroidism (HPT) in patients with chronic kidney disease (CKD) on dialysis. It is also indicated in adults for the treatment of hypercalcemia in patients with parathyroid cancer and severe hypercalcemia in patients with primary HPT who are unable to undergo parathyroidectomy. The medication is used to decrease the release of parathyroid hormone (PTH) from the parathyroid gland. Sensipar lowers high PTH levels leading to lower calcium levels in the blood; when calcium levels are too low it can result in health problems.
This announcement does not mean that the FDA has concluded whether or not Sensipar had a role in the patient’s death. The FDA is evaluating the information and will communicate its final conclusions and recommendations when its review is complete.
The FDA reminded health care professionals:
- Sensipar lowers calcium levels in the blood. Patients should be monitored for the development of low serum calcium levels (hypocalcemia).
- The potential signs of low serum calcium levels include muscular problems such as muscle cramping, tetany, convulsions, paresthesias, and myalgias.
- If serum calcium levels decrease below the normal range, appropriate steps should be taken to increase calcium levels, such as by providing supplemental calcium, initiating or increasing the dose of a calcium-based phosphate binder, initiating or increasing the dose of vitamin D sterols, or temporarily withholding treatment with Sensipar.
- Serum calcium levels should be measured within one week after initiation or dose adjustment of Sensipar. Once a maintenance dose has been established, serum calcium should be measured monthly.
- The most frequently reported side effects in adult clinical trials of Sensipar were nausea, vomiting, and diarrhea.
See the FDA Safety Announcement