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Health professional risk communication

SAMSCA (tolvaptan) - Potential Risk of Liver Damage - For the Public

Starting date:
March 1, 2013
Posting date:
March 1, 2013
Type of communication:
Public Communication
Subcategory:
Drugs
Source of recall:
Health Canada
Audience:
General Public
Identification number:
RA-23679

This is duplicated text of a letter from Otsuka Canada Pharmaceutical Inc. Contact the company for a copy of any references, attachments or enclosures.

Notice about Health Canada advisories

PUBLIC COMMUNICATION - Health Canada Endorsed Important Safety Information on SAMSCA (tolvaptan)

March 1, 2013

Subject: Association of SAMSCA® (tolvaptan) with a potential risk of liver damage

Otsuka Canada Pharmaceutical Inc. (Otsuka), in association with Health Canada, would like to inform you of important new safety information related to the potential risk of serious liver damage associated with the use of SAMSCA® (tolvaptan). Three (3) cases of liver damage were reported during clinical trials to study tolvaptan for the treatment of Autosomal Dominant Polycystic Kidney Disease (ADPKD).

SAMSCA is a drug currently approved to treat certain patients with clinically important, non-hypovolemic hyponatremia (low blood sodium levels). There was no liver damage reported in other clinical trials supporting the current approved use of SAMSCA. However, this is not sufficient to rule out the risk of liver damage for any patient taking SAMSCA.

  • SAMSCA has the potential to cause irreversible and potentially fatal liver damage.
  • Patients should immediately contact their doctor or pharmacist if they experience any of the following symptoms:
    • fatigue
    • loss of appetite
    • right upper abdominal discomfort
    • dark urine
    • jaundice (yellowing of the skin or eyes)

During clinical trials to study tolvaptan for the treatment of ADPKD, three patients out of the 958 developed liver damage while taking a higher dose ranges of tolvaptan (60-120 mg daily) than normally indicated (15-60 mg daily). When the treatment was stopped, the liver functions of these three (3) patients improved. No cases of liver failure were observed in this study. The use of SAMSCA in the treatment of ADPKD has not been approved by any Health Authorities including Health Canada.

Otsuka has sent a letter to healthcare professionals to inform them of this new safety information. A copy of this letter is available on Health Canada’s website.

Managing marketed health product-related side effects depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing side effects are generally presumed to underestimate the risks associated with health product treatments. Any case of serious hepatic injury or other serious or unexpected side effects in patients receiving SAMSCA should be reported to Otsuka or Health Canada immediately:

Otsuka Canada Pharmaceutical Inc.
2250 Alfred Nobel Blvd.
Saint-Laurent, Quebec
H4S 2C9
Phone: 1-877-341-9245
Fax:  1-905-689-1465

You can report any suspected side effect associated with the use of health products to Health Canada by:

  • Calling toll-free at 1-866-234-2345; or

For other health product inquiries related to this communication, please contact Health Canada at:
Marketed Health Products Directorate
E-mail: mhpd_dpsc.public@hc-sc.gc.ca
Telephone: 613-954-6522
Fax: 613-952-7738

If you have any questions or need additional information about SAMSCA, please contact Otsuka Medical Information at 1-877-341-9245.

original signed by

Otsuka Canada Pharmaceutical Inc.
per:
Khalid Mezzi, MD
Director, Medical Affairs