February 27, 2013
FDA Halts Pediatric Trials Of Sensipar Following Teenager’s Death
redOrbit Staff & Wire Reports - Your Universe Online
Officials with the US Food and Drug Administration (FDA) have halted a trial of the thyroid drug Sensipar following the death of a 14-year-old patient during clinical trials, various media outlets reported Tuesday.
According to the Associated Press (AP), officials from the regulatory agency are still gathering information about the incident. However, in the meantime they have ordered the drug´s manufacturer, biopharmaceutical firm Amgen Inc., to cease all pediatric trials of Sensipar, which is used to treat overactive parathyroid glands in adults.
The drug, which was approved for use in adults in 2004, was being tested by the company to determine whether or not it could be safely and effectively used to treat children under the age of 18, Anna Edney of Bloomberg News said. It remains unclear at this point whether or not Sensipar was directly involved with the unnamed patient´s death, she added. The FDA plans to announce their findings at the conclusion of their investigation.
“Amgen is working as rapidly as possible to understand the circumstances of what happened,” Ashleigh Koss, a spokeswoman for the California-based company, told Bloomberg via email “This analysis is ongoing and will be concluded as quickly as possible.”
Sensipar decreases the release of parathyroid hormone from the parathyroid gland, thus decreasing the calcium levels in the patient´s blood, explained Reuters reporter Bill Berkrot. Should those blood calcium levels become too elevated, severe health problems could arise.
Sensipar accounted for a reported five percent of Amgen´s total sales in 2011, earning more than $950 million worldwide. There were three pediatric studies for the drug dating back to 2010 listed on the National Institute of Health´s (NIH) Clinical Trials website, Edney said, and the most frequently listed side effects experienced by adults during clinical trials were nausea, vomiting and diarrhea, according to the FDA.
“The trials were being conducted to determine the safety and efficacy of the drug in younger patients,” Berkrot said. “Drugmakers also often conduct pediatric trials because they are rewarded with an additional six months of patent protection for testing medicines in children.”