Health & Medicine
FDA Stops Trial of Amgen Inc's Sensipar after 14-year-Old's Death, Decreases Parathyroid Hormone
Kathleen Lees
First Posted: Feb 26, 2013 08:18 PM EST
Pediatric clinical trials of the drug Amgen Inc's Sensipar have been halted after the death of a 14-year-old patient took part in the study of the drug, according to the Food and Drug Administration.
Sensipar, which is approved for adults, is used to lower dangerously high calcium levels in the blood.
The agency is currently collecting information regarding the circumstances surrounding the teenager's death. At this time, they are uncertain, according to reports, if the drug had anything to do with the 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," the FDA said in a statement posted on its website.
Amgen, the world's largest biotechnology company, said it had sent a letter last week to healthcare providers alerting them to the trials' halt and the patient death, according to Reuters.
"Amgen is working as rapidly as possible to understand the circumstances of what happened. This analysis is ongoing and will be concluded as quickly as possible," the company said in a statement.
Sensipar works by decreasing the release of parathyroid hormone from the parathyroid gland to lower calcium levels in the blood. High levels of calcium in the blood can lead to serious health problems, according to reports.Sensipar, which had worldwide sales of $950 million in 2012, is approved to treat adults 18 and over. The trials were conducted to determine the safety and efficacy of the drug in younger patients.
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First Posted: Feb 26, 2013 08:18 PM EST
Pediatric clinical trials of the drug Amgen Inc's Sensipar have been halted after the death of a 14-year-old patient took part in the study of the drug, according to the Food and Drug Administration.
Sensipar, which is approved for adults, is used to lower dangerously high calcium levels in the blood.
The agency is currently collecting information regarding the circumstances surrounding the teenager's death. At this time, they are uncertain, according to reports, if the drug had anything to do with the 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," the FDA said in a statement posted on its website.
Amgen, the world's largest biotechnology company, said it had sent a letter last week to healthcare providers alerting them to the trials' halt and the patient death, according to Reuters.
"Amgen is working as rapidly as possible to understand the circumstances of what happened. This analysis is ongoing and will be concluded as quickly as possible," the company said in a statement.
Sensipar works by decreasing the release of parathyroid hormone from the parathyroid gland to lower calcium levels in the blood. High levels of calcium in the blood can lead to serious health problems, according to reports.Sensipar, which had worldwide sales of $950 million in 2012, is approved to treat adults 18 and over. The trials were conducted to determine the safety and efficacy of the drug in younger patients.
See Now: NASA's Juno Spacecraft's Rendezvous With Jupiter's Mammoth Cyclone