FDA halts pediatric trials of Sensipar(Amgen) for Hyperparathyroidism
The FDA has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) from Amgen, after the recent death of a 14-year-old patient in a trial. The 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.
The 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.
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