FDA Halts Pediatric Trials for Sensipar After Teen’s Death

Irvin Jackson

Add Your Comments

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

Do You Know about…

Spinal Cord Stimulator lawsuits

Spinal cord stimulator lawsuits are being investigated for individuals who suffered unnecessary shocks, burns or other problems, often resulting in the need for additional surgery to remove the SCS.

Learn More
SEE IF YOU QUALIFY FOR COMPENSATION
Spinal-Cord-Stimulation-Lawsuit
Spinal-Cord-Stimulation-Lawsuit

Do You Know About…

Spinal Cord Stimulator lawsuits

Spinal cord stimulator lawsuits are being investigated for individuals who suffered unnecessary shocks, burns or other problems, often resulting in the need for additional surgery to remove the SCS.

Learn More
SEE IF YOU QUALIFY FOR COMPENSATION

“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.

Written by: Irvin Jackson

Senior Legal Journalist & Contributing Editor

Irvin Jackson is a senior investigative reporter at AboutLawsuits.com with more than 30 years of experience covering mass tort litigation, environmental policy, and consumer safety. He previously served as Associate Editor at Inside the EPA and contributes original reporting on product liability lawsuits, regulatory failures, and nationwide litigation trends.

Tags: Amgen, Cancer, Childrens Drug, Kidney, Sensipar

More Lawsuit Stories

0 Comments

This field is for validation purposes and should be left unchanged.

Share Your Comments

This field is hidden when viewing the form
I authorize the above comments be posted on this page
Post Comment
Weekly Digest Opt-In

Want your comments reviewed by a lawyer?

To have an attorney review your comments and contact you about a potential case, provide your contact information below. This will not be published.

NOTE: Providing information for review by an attorney does not form an attorney-client relationship.

MORE TOP STORIES

Abbott, Boston Scientific Oppose Spinal Cord Stimulator Lawsuit MDL
Both Abbott Laboratories and Boston Scientific are fighting against a call by plaintiffs to consolidate all spinal cord stimulator lawsuits before one federal judge for pretrial proceedings.
Depo-Provera-Brain-Tumor-Symptoms
More than 4,000 women across the U.S. have filed product liability lawsuits and medical monitoring class action claims seeking compensation for potential brain tumor symptoms and side effects allegedly caused by Depo-Provera.
Uber Settlements Reached To Resolve Certain Sexual Assault Lawsuits
Plaintiffs in Uber driver sexual assault lawsuits have asked a federal judge to approve a Common Benefit Funds motion, which is usually a sign of some form of settlement agreement.