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FDA Drug Safety Communication: Pediatric clinical studies of Sensipar (cinacalcet hydrochloride) suspended after report of death

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[2-26-2013] The U.S. Food and Drug Administration (FDA) has placed a clinical hold on all pediatric clinical studies of Sensipar (cinacalcet hydrocloride) after the company that makes the drug, Amgen, suspended the studies after the recent death of a 14-year-old patient in a study. FDA continues to gather information on the circumstances surrounding the patient’s death.   Sensipar is a medication 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.  FDA has approved Sensipar for use in adults but not in children (less than 18 years of age), and the clinical studies were underway to determine if the drug is effective and can be used safely in children.

Posting this information does not mean that FDA has concluded whether or not Sensipar had a role in the patient’s death. This communication is intended to inform health care professionals that we are evaluating the information and will communicate our final conclusions and recommendations when our review is complete.

At this time, we remind health care professionals of the following:

  • 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 1 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.

FDA has not approved Sensipar for use in children.  Sensipar 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

We urge both health care professionals and patients to report adverse events involving Sensipar to the FDA MedWatch program, using the information in the “Contact FDA” box at the bottom of the page.

 

Contact FDA

1-800-332-1088
1-800-FDA-0178 Fax
Report a Serious Problem

MedWatch Online

Regular Mail: Use postage-paid FDA Form 3500

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