The U.S. Food and Drug Administration on Tuesday announced it had stopped all clinical pediatric trials for Sensipar an Amgen, Inc. drug following the death of a patient who was 14 years old, who had been taking part in the study of Amgen’s drug.
Sensipar, which is already approved for use by adults, is used to help lower calcium levels that are dangerously high in blood.
The FDA said it was in the process of collecting data on the teenager’s death. The regulatory agency said it did not know whether the Amgen drug was involved in the death of the teenager.
Amgen is the largest biotechnology business in the world and said last week that it had sent a letter to all healthcare providers alerting them of the halt in the clinical trials and of the death of the patient.
A statement provided by Amgen said it was working as quickly as possible to learn the circumstances of the teenager’s death. The analysis is continuing and will be concluded as rapidly as possible, said the company’s statement.
The drug works by lowering the release of the hormone parathyroid from the gland of the same name to lower the levels of calcium in the blood. High calcium levels in blood can lead to severe health problems.
Sensipar, with sales worldwide of over $950 million during 2012, has been approved for people 18 or over. The clinical trials were taking place to determine the efficacy and safety of the medication in patients who are younger.
