FDA halts pediatric clinical trials of Sensipar following death
The FDA has stopped all pediatric clinical trials of cinacalcet hydrochloride following the death of a pediatric patient (aged 14 years) in a trial, according to a press release on the agency’s website today.
In a separate press release, the FDA wrote that they continue to collect information on the circumstances surrounding the death.
Cinacalcet hydrochloride (Sensipar, Amgen) is a calcium-sensing receptor agonist indicated for secondary hyperparathyroidism in patients with chronic kidney disease on dialysis; hypercalcemia in patients with parathyroid cancer; and severe hypercalcemia in patients with primary hyperparathyroidism who are unable to undergo parathyroidectomy. It is not currently approved for children aged younger than 18 years. According to the press release, clinical trials had been underway to determine the safety and efficacy of therapy in pediatric patients.
The drug works by decreasing the release of parathyroid hormone (PTH) from the parathyroid gland. It lowers high PTH levels leading to lower calcium levels in the blood; when calcium levels are too low it can result in health problems, according to the press release.
The FDA cautions that this announcement does not conclude that cinacalcet hydrochloride caused the death in a pediatric patient. However, they communicate that evaluations are ongoing and final recommendations will be released when review of this circumstance is complete.
In the press release, the FDA reminds health care professionals of the following:
- Cinacalcet hydrochloride 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 cinacalcet hydrochloride.
- Serum calcium levels should be measured within 1 week after initiation or dose adjustment of cinacalcet hydrochloride. Once a maintenance dose has been established, serum calcium should be measured monthly.
- The most frequently reported side effects in adult clinical trials of cinacalcet hydrochloride were nausea, vomiting, and diarrhea.
For more information, visit www.fda.gov.