FDA halts trials of Amgen drug in children, cites death

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The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009. REUTERS/Jason Reed

The corporate logo of the U.S. Food and Drug Administration (FDA) is shown in Silver Spring, Maryland, November 4, 2009.

Credit: Reuters/Jason Reed

Tue Feb 26, 2013 12:31pm EST

(Reuters) – 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 website.

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.

(Reporting by Bill Berkrot; Editing by David Gregorio)

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