Feb 26 The U.S. Food and Drug Administration
said on Tuesday it has stopped all pediatric clinical trials of
Amgen Inc's Sensipar after the reported death of a
14-year-old patient taking part in a study of the drug used to
lower calcium levels in the blood.
The agency said it was collecting information on the
circumstances of the teenager's death. It said it does not know
if the Amgen drug, used to lower dangerously high calcium levels
in the blood, had any role in 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
Sensipar is approved to treat adults 18 and over. The trials
were being conducted to determine the safety and efficacy of the
drug in younger patients.
Drugmakers also often conduct pediatric trials because they
are rewarded with an additional six months of patent protection
for testing medicines in children.