Narrator: Welcome to the FDA Drug Safety Podcast from the Division of Drug Information. Today’s topic: FDA suspends pediatric clinical trials of Sensipar (active ingredient cinacalcet hydrochloride) after report of death
US Public Health Service Pharmacist LCDR Jennifer Shepherd in the Division will provide you with additional information about this Communication.
LCDR Shepherd: On February 26, 2013, the FDA issued a Drug Safety Communication informing the public it has stopped all pediatric clinical trials of Sensipar after the recent death of a 14-year-old patient in a trial. 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 (or 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 trials 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.
It should be noted 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
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 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.
- We urge both health care professionals and patients to report adverse events involving Sensipar to the FDA MedWatch program at www.fda.gov/MedWatch.
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