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Health professional risk communication

Archived - Association of PREZISTA (darunavir) with hepatotoxicity

Starting date:
May 12, 2008
Posting date:
May 15, 2008
Type of communication:
Public Communication
Source of recall:
Health Canada
General Public
Identification number:

This is duplicated text of a letter from Janssen-Ortho 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 PREZISTA* (darunavir)

May 12, 2008

Subject: New safety information regarding PREZISTA* (darunavir) and serious liver side effects

Tibotec, a division of Janssen-Ortho Inc. ("Tibotec"), in cooperation with Health Canada, wishes to provide patients with important new safety information about serious liver side effects that have been reported with PREZISTA (darunavir).

PREZISTA is a medication used in combination with ritonavir, another antiretroviral medication, to treat adult patients with human immunodeficiency virus (HIV) in whom other antiretroviral therapy has failed.

  • Among patients participating in clinical studies, 0.5% experienced hepatitis (inflammation of the liver) while being treated with PREZISTA.
  • There have been 13 post market reports of patients taking PREZISTA who developed hepatitis during the time period from June 23, 2006 to December 23, 2007, including 2 patients who died. During that same period, there also have been 25 reports of patients who developed other liver problems, including 14 patients who died.
  • It has not been established if PREZISTA contributed to these adverse liver events and deaths, or if they were due to other reasons, such as other medical problems or other medications. These reports generally involved patients with advanced HIV disease who were taking other medications, or had other illnesses such as hepatitis B or C infection, or a condition called immune reconstitution syndrome.
  • Patients who have liver problems (including infection with hepatitis B or C virus) before starting treatment with PREZISTA are at greater risk for serious adverse liver events.

Your doctor will likely want to test your liver function before and during treatment with PREZISTA. If you have a liver problem before starting treatment, your doctor may choose to test your liver function more often.

If you use PREZISTA, you should consult a doctor immediately if you experience any of the following signs or symptoms suggestive of possible serious liver side effects:

  • dark urine
  • yellowing of the skin
  • abdominal pain, especially on the right side below the ribs
  • general itchiness
  • decreased appetite
  • nausea or vomiting
  • tiredness

Patients should NOT discontinue their medication without consulting a doctor or pharmacist first.

Tibotec is working with Health Canada to update the prescribing information for PREZISTA and has sent a letter to health care professionals and pharmacists to inform them of this new safety information. A copy of that letter is available on the Health Canada website.

This information is also available at the Janssen-Ortho Inc. website. For more information, patients should consult their health care professionals, or call the Janssen-Ortho Medical Information Department at 1-800-567-3331, from 8:30 a.m. to 4:30 p.m. Monday to Friday, EST.

Managing marketed health product-related adverse reactions depends on health care professionals and consumers reporting them. Reporting rates determined on the basis of spontaneously reported post-marketing adverse reactions are generally presumed to underestimate the risks associated with health product treatments. Any case of serious or unexpected adverse reactions in patients receiving PREZISTA should be reported to Tibotec or Health Canada at the following addresses:

Tibotec, a division of Janssen-Ortho Inc.
Drug Safety Department
19 Green Belt Drive
Toronto, ON M3C 1L9
Tel: 800-567-3331 or Fax: 866-767-5865

Any suspected adverse reaction can also be reported to:
Canada Vigilance Program
Marketed Health Products Directorate
Health Canada
Address Locator: 0701C
Ottawa, Ontario, K1A 0K9
Tel: 613-957-0337 or Fax: 613-957-0335
To report an Adverse Reaction, consumers and health professionals may call toll free:
Tel: 866-234-2345
Fax: 866-678-6789

The AR Reporting Form and the AR Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties.

For other inquiries related to this communication, please contact Health Canada at:
Bureau of Gastroenterology, Infection and Viral Diseases (BGIVD)
Marketed Health Products Directorate (MHPD)
Tel: 613-941-2566
Fax: 613-941-1183


original signed by

Cathy Lau, PhD.

Vice President
Regulatory Affairs
Janssen-Ortho Inc.

* All trademark rights used under license