Health Canada cautions against use of Sensipar in children

Starting date:

March 7, 2013

Posting date:

March 7, 2013

Type of communication:

Information Update

Subcategory:

Drugs, Affects children, pregnant or breast feeding women

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-25849

• 
  Issue
• 
  What you should do
• 
  Report health or safety concerns
• 
  Related AWRs
• 
  Media enquiries
• 
  Public enquiries

Issue

Following the death of a child enrolled in a clinical trial for the drug Sensipar in the United States, Health Canada is reminding healthcare professionals and consumers that Sensipar is not approved for use in patients under 18 years of age.

Sensipar (cinacalcet) is used for treating disorders of the parathyroid gland that result in high blood calcium levels.

Amgen, the manufacturer of Sensipar, recently halted all pediatric clinical trials of the drug after the death of a 14-year-old patient who developed very low blood calcium levels during a trial. It has not been determined whether Sensipar had a role in the patient's death. There have been no clinical trials of Sensipar involving children in Canada.

As indicated in the drug label, Sensipar is not approved for use in children. No adverse reactions to Sensipar involving a patient under 18 years of age have been reported to Health Canada. The risk of low blood calcium levels associated with the use of Sensipar is already part of the product labelling.

Health Canada is currently reviewing available safety information and will consider updating the labelling information, as appropriate.

What you should do

Patients with questions or concerns about their Sensipar treatment should speak to their healthcare professional.

Additional information for healthcare professionals

The Canadian drug label for Sensipar warns about the risk of hypocalcemia (low blood calcium levels) associated with its use. Healthcare professionals should carefully monitor patients for this risk. Symptoms of hypocalcemia include convulsions, irregular heartbeat, involuntary contraction of muscles and numbness (hands, feet, mouth, lips).

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

Related AWRs

New heart warnings for the drug Sensipar

2013-10-15 | Health products

Advisory

Media enquiries

Health Canada

(613) 957-2983

Public enquiries

(613) 957-2991

1-866 225-0709