Archived - APTIVUS (tipranavir) - Advisories, Warnings and Recalls for the Public

Starting date:

July 6, 2006

Posting date:

July 6, 2006

Type of communication:

Public Communication

Subcategory:

Drugs

Source of recall:

Health Canada

Audience:

General Public

Identification number:

RA-19000391

This is duplicated text of a letter from Boehringer Ingelheim (Canada) Ltd.

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 APTIVUS^® (tipranavir)

July 6, 2006

Subject: New Safety Information Regarding Risk of Intracranial Hemorrhage in HIV Patients using Aptivus^® (tipranavir)

Boehringer Ingelheim, in collaboration with Health Canada, is informing you of new safety information regarding APTIVUS (tipranavir), a medication used in adult HIV patients who have not responded to other medications.

Boehringer Ingelheim has identified 14 cases of intracranial hemorrhage (ICH) (bleeding into the brain), including 8 deaths, in 6,840 HIV-1 infected patients receiving APTIVUS in clinical trials.

In more than half of the 14 cases, patients experiencing ICH also had other medical conditions or were taking other medications, including anti-coagulants (blood thinners) and anti-platelet (anti-clotting) agents, which may have contributed to these events.

No pattern of abnormal blood clotting was seen in these patients, however in the test tube, tipranavir has been shown to have effects on platelet clumping similar to those of aspirin. Platelets are blood elements important for blood clotting (stopping bleeding).

Patients taking APTIVUS should not discontinue or modify their treatment with APTIVUS or any other medication, without first consulting their doctor to discuss the most appropriate therapy for their individual treatment needs.

The Product Monograph for APTIVUS is in the process of being updated to reflect this new safety information. Boehringer Ingelheim has also issued a letter to health professionals advising them of this new safety information.

A copy of the letter to health professionals and this communication will be posted on Boehringer Ingelheim's www.boehringer-ingelheim.ca and Health Canada's web site.

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 intracranial bleeding or any other serious adverse event occurring in patients receiving APTIVUS should be reported to Boehringer Ingelheim or Health Canada at the following addresses:

Boehringer Ingelheim (Canada) Ltd.

Manager, Drug Safety

5180 South Service Road

Burlington, Ontario L7L 5H4

call toll free at 1-800-263-5103 Ext. 4603

Fax at: 905-333-4464

Any suspected adverse incident can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)

Marketed Health Products Directorate

Health Canada

Address Locator: 0701C

Ottawa, Ontario, K1A 0K9

Tel: (613) 957-0337

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

cadrmp@hc-sc.gc.ca

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)

E-mail: BGIVD_Enquiries@hc-sc.gc.ca

Tel: (613) 941-3207

Fax: (613) 941-1183

Sincerely,

original signed by

Tomasz Uscinowicz, MD

Vice President, Medical