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FDA Halts Clinical Trials of Thyroid Drug Sensipar (Cinecalcet) in Children
Agency cites death of 14-year-old patient (Feb. 26)
The FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet, Amgen) after the recent death of a 14-year-old patient in a study. The agency continues to gather information on the circumstances surrounding the patient’s death.
Sensipar decreases the release of parathyroid hormone (PTH) from the parathyroid gland. The drug lowers high PTH levels, which leads to lower calcium levels in the blood; when calcium levels are too low, it can result in health problems. The FDA has approved Sensipar for use in adults but not in children (i.e., those younger than 18 years of age), and the clinical trials were under way to determine whether the drug is safe and effective in pediatric patients.
The FDA has not concluded whether Sensipar had a role in the patient’s death. In a communication posted on its Web site, the agency states that it is evaluating the information and will communicate its final conclusions and recommendations when its review is complete.
At the present time, the FDA reminds health care professionals of the following:
- Sensipar (cinecalcet) lowers calcium levels in the blood. Patients should be monitored for the development of hypocalcemia.
- The potential signs of hypocalcemia 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 these 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 1 week after the 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 clinical trials of Sensipar in adults were nausea, vomiting, and diarrhea.
The FDA has not approved Sensipar for use in children. The drug 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
- Severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy
The agency urges both health care professionals and patients to report adverse events involving Sensipar to the FDA MedWatch program.
Source: FDA; February 26, 2013.