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The Division of Drug Information (DDI) is CDER's focal point for public inquiries. We serve the public by providing information on human drug products and drug product regulation by FDA.
The U.S. Food and Drug Administration (FDA) has stopped all pediatric clinical trials of Sensipar (cinacalcet hydrochloride) 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 (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.
For more information please visit: Sensipar
This is an automated message delivery system. Replying to this message will not reach DDI staff. If you have comments or questions, please contact us at: 1-888-INFO FDA (1-888-463-6332) or (301) 796-3400 from 8:00 am - 4:30 pm Monday - Friday. You can also email us at druginfo@fda.hhs.gov.
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