The U.S. Food and Drug Administration (FDA) announced that it has halted Amgen Inc.’s study of its thyroid drug Sensipar (cinacalcet) in children after the death of a 14-year-old patient in a clinical trial.
The FDA said that, at this time, it is not certain whether Sensipar had a role in the teenager’s death, USA Today reports, but the agency has halted the clinical trial until it can evaluate the information.
Sensipar was approved in 2004 to treat adults with hyperactivity of the parathyroid gland. Amgen had been conducting clinical trials to determine whether the drug is effective for children under 18. In a Safety Alert posted on its web site on February 26, the FDA reminds doctors to exercise caution in prescribing Sensipar. Patients’ serum calcium levels—calcium in the blood—should be carefully monitored to make sure they don’t fall to dangerously low levels (hypocalcemia). Sensipar lowers calcium levels in the blood. The FDA recommends that calcium levels be checked within one week of starting Sensipar or adjusting the dose. Once a maintenance dose has been established, the agency said, calcium levels should be measured monthly.
