The US Food and Drug Administration (FDA) today announced that it has halted all pediatric clinical trials of cinacalcet (Sensipar, Amgen), a calcium-lowering drug, after the recent death of a 14-year-old patient in a study.
The FDA decision to stop the trials is precautionary because it has not concluded whether cinacalcet played a role in the child's death. The agency is investigating the fatality and will report its findings and recommendations once it completes the review.
Cinacalcet is indicated for the treatment of secondary hyperparathyroidism in patients with chronic kidney disease who are receiving dialysis, hypercalcemia in patients with parathyroid carcinoma, and severe hypercalcemia in patients with primary hyperparathyroidism who cannot undergo parathyroidectomy. It is currently approved for use only in adults.
The clinical trials halted by the FDA were attempting to determine whether cinacalcet is an effective and safe drug for patients younger than 18 years.
Cinacalcet works by decreasing the output of parathyroid hormone from the parathyroid gland. By lowering high parathyroid hormone levels, the drug can lower dangerously high calcium levels in the bloodstream. However, the drug's label warns that there is the risk of the pendulum swinging from hypercalcemia to hypocalcemia.
In its announcement today, the FDA reminded clinicians to monitor adult patients taking cinacalcet for signs of low serum calcium levels such as muscle cramping, tetany, convulsions, paresthesias, and myalgias. They should measure serum calcium levels 1 week after beginning a patient on cinacalcet or adjusting the dose, and once a month afterward. If calcium levels drop below normal, clinicians should try to boost them by providing supplemental calcium, initiating or increasing the dose of a calcium-based phosphate binder or vitamin D sterols, or temporarily halting treatment with cinacalcet.
The FDA-approved label for cinacalcet also warns of the risk for adynamic bone disease, hepatic impairment, and various cardiac problems.
More information about today's announcement is available on the FDA Web site.
To report problems with cinacalcet, contact MedWatch, the FDA's safety information and adverse event reporting program, by telephone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; online athttps://www.accessdata.fda.gov/scripts/medwatch/medwatch-online.htm; with postage-paid FDA form 3500, available at http://www.fda.gov/MedWatch/getforms.htm; or by mail to MedWatch, 5600 Fishers Lane, Rockville, Maryland 20852-9787.
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