FDA

Death of Teenager Halts Clinical Trial

FDAThe U.S. Food and Drug Administration (FDA) has suspended all pediatric clinical trials of the calcium-reducing drug Sensipar. This comes after the death of a 14-year-old boy who was involved in a clinical trial. Sensipar, developed by Amgen, Inc., also known by its scientific name Cinicalcet hydrochloride, has been tested for its suitability for use in children under less than 18 years of age. Currently, the calcium reducer is approved by the FDA for use by adults, but not by those under 18 years.

The FDA has yet to make a decision on whether the drug played a role in the death of the teenager, but it has halted all ongoing trials as a precaution as the organization evaluates the death. Upon determining the cause of death and the role Sensipar played in it, the FDA will make public its findings and determine whether current and future trials can proceed as planned.

Sensipar has been proven to be a popular drug in the fight to reduce the levels of calcium in the blood stream in adults with sales nearing $950 million in 2012. The drug is used to reduce calcium levels and decrease the release of high levels of the parathyroid hormone responsible for producing high levels of calcium. The drug is most commonly used to help treat patients with chronic kidney disease on dialysis, parathyroid cancer and those with hypercalcemia. Because of the high levels of use and success rate of Sensipar, researchers were hopeful clinical trials would make it widely available for children with high calcium levels within their bodies.

High levels of calcium within the body have been linked to a number of high-risk medical conditions, including heart disease. A number of side effects have been identified as affecting patients taking the calcium suppressor with the most common side effects identified as vomiting, nausea and diarrhea. Because of the effectiveness of Sensipar as a calcium reducer, medical professionals are advised to ensure levels are constantly monitored in patients taking the drug in order to avoid any problems caused by low calcium levels. Symptoms of low calcium in humans include cramping of the muscles, muscle pain and convulsions.

Additional Reading:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/
SafetyAlertsforHumanMedicalProducts/ucm341255.htm
http://medical-dictionary.thefreedictionary.com/Sensipar
http://www.medicalnewstoday.com/articles/256971.php