FDA Halts Pediatric Trials for Sensipar After Teen’s Death

Following the death of a 14-year-old test subject, federal health regulators have forced Amgen to halt pediatric trials of the drug Sensipar (cinacalcet), which is currently only approved for use by adults. 

The FDA announced that it was shutting down Sensipar pediatric clinical trials on February 26, citing the unidentified teenager’s death as the reason. However, the agency indicates that it has not conclusively linked the use of Sensipar to the death.

Earlier this month, Amgen sent a letter to health care professionals (PDF) announcing the death and the end to the clinical trials. The drug maker indicated that the child died from severely low calcium levels, which is a known side effect of Sensipar

“Amgen has suspended dosing and enrolment in all pediatric cincacalcet investigational studies to ensure the safety of all patients enrolled in these studies and is investigating this case to determine if any additional actions are necessary,” the letter states.

Sensipar has been approved for use in adults since 2004 for the treatment of kidney disease and parathyroid cancer. The drug works by lowering high parathyroid hormone levels, which lead to lower calcium levels in the blood. However, when calcium levels drop too low it can cause hypocalcemia, which can lead to a number of health problems.

While Sensipar is not approved by the FDA for use in children, doctors are able to legally prescribe it “off-label”. However, Amgen is not able to market the drug for use in children until after they have received FDA approval, based on studies demonstrating that it is safe and effective.

The FDA is advising health care professionals who prescribe Sensipar to monitor patients for the development of low serum calcium levels. The symptoms can include muscle problems such as:

• Muscle cramping
• Tetany
• Convulsions
• Paresthesias
• Myalgias

The FDA recommends that patients who have hypocalcemia should be treated to increase their calcium levels, which can be done by supplemental calcium, calcium-based phosphate binders, vitamin D sterols, or by temporarily halting Sensipar treatment.