Archived - Letter to Hospitals Re: Abbokinase

Starting date:

February 4, 1999

Posting date:

February 4, 1999

Type of communication:

Notice to Hospitals

Subcategory:

Biologic/vaccine

Source of recall:

Health Canada

Audience:

Healthcare Professionals

Identification number:

RA-1700045

• Affected products
• Related AWRs

Notice about Health Canada advisories

Therapeutic Products Programme
Tunney's Pasture
Address Locator #0603D
Ottawa, Ontario
K1A 0L2

DTS #: 9 9 -004459

February 4, 1999

Dear Sir/Madam:

The purpose of this letter is to update you on important safety information regarding the use of Abbokinase (Urokinase) for injection. This information is intended to help physicians and patients understand the potential risks of transmitting infectious agents associated with the use of this product. The Therapeutic Products Programme (TPP) of Health Canada is recommending that Abbokinase be reserved for those situations where a physician has considered the alternatives and has determined that the use of Abbokinase is critical to the care of a specific patient in a specific situation.

During recent inspections of Abbott Laboratories and its supplier of the human neonatal kidney cells used in the manufacture of Abbokinase, the United States Food and Drug Administration (FDA) identified numerous significant deviations from the Current Good Manufacturing Practice regulations designed to help assure product safety. Abbokinase is approved in Canada for the lysis of acute massive pulmonary emboli and for the restoration of potency to intravenous catheters, including central venous catheters, obstructed by clotted blood or fibrin (under the trade name Abbokinase Open-Cath). Each lot of Abbokinase sold in Canada requires release by the Bureau of Biologics and Radiopharmaceuticals (BBR). Following the U.S. FDA action, BBR suspended the release of any future lots of Abbokinase until the problems observed during the inspection are resolved. Until this time, new supplies of Abbokinase will be available only via the Special Access Programme.

Abbokinase is produced from primary cultures of kidney cells harvested post-mortem from human neonates. Products manufactured from human source materials have the potential to transmit infectious agents. While some procedures to help control such risks in products of human source are in place, the recent inspection revealed deficiencies in some of the procedures used by Abbott and its supplier of the human neonatal kidney cells that could increase the risk of transmitting infectious agents. In considering this risk, the prescriber should be aware of the following information, based on the FDA inspection observations, regarding currently available lots of Abbokinase, and to aid in the careful consideration of any future Special Access requests.

The kidney cells used in the manufacture of this product were harvested post-mortem from human neonates from a population at high risk for a variety of infectious diseases, including tropical diseases. The screening of potential donors did not include the questioning of the mothers to determine infectious disease status or specific risk factors for infectious diseases. Although some efforts were made by Abbott's supplier to screen and test the mothers, neonate donors, and kidney cells, Abbott's testing of the materials it received indicates that these measures were not consistently or reliably performed.

Neither the mothers nor the neonate donors were tested for hepatitis C virus (HCV) infection. Abbott has recently instituted a test for HCV in the kidney cells used in the manufacture of Abbokinase and negative test results have been obtained for currently available lots. However, Abbott has not validated this test.

Prior to use in the manufacture of Abbokinase, the human kidney cells were harvested, stored and handled in a manner which may have permitted contamination with infectious agents.

A viral inactivation procedure that substantially inactivates HIV and HCV in other biological products was used in the production of the currently available lots of Abbokinase. This process has variable effects on other infectious agents and has not been fully validated for viral inactivation of Abbokinase.

The TPP is not aware of any cases of infectious diseases that can be attributed to the use of Abbokinase. However, the likelihood that cases of infectious diseases caused by Abbokinase, if any, would have been recognized as such and reported to the TPP is probably very low. Therefore, the actual risk to patients of developing an infectious disease as a result of using Abbokinase is unknown. For each setting in which the use of Abbokinase is being contemplated, we encourage you to consider the appropriateness of other treatment options.

A list of other thrombolytic products approved in Canada is appended.

Yours sincerely,
(Original signed by)

K. Bailey, D.Phil.
Director
Bureau of Biologics and
Radiopharmaceuticals
Tel: (613) 957-8064
Fax: (613) 957-6302
E-mail: Keith_Bailey@hc-sc.gc.ca

Attachments

Proper Name	Trade Name	Approved Indication	Submission Sponsor
Alteplase (Analogue)	Retavase	Management of Acute Myocardial Infarction (AMI)	Crystaal Corporation 2480 Dunwin Drive Mississauga, Ontario L5L 1J9
Alteplase	Activase rt-PA	the lysis of suspected occlusive coronary artery thrombi associated with evolving transmural myocardial infarction; the reduction of mortality associated with AMI, the improvement of ventricular function following AMI and the reduction in the incidence of congestive heart failure.	Hoffmann-La Roche Ltd. 2455 Meadowpine Blvd. Mississauga, Ontario L5N 6L7
Anistreplase	Eminase	Management of AMI	Roberts Pharmaceuticals Canada Inc. 400 Iroquois Shore Road Oakville, Ontario L6H 1M5
Streptokinase	Streptase	Management of AMI; Lysis of Pulmonary Embolism; Treatment of Deep Vein Thrombosis; For the treatment of Arterial Thrombosis and Embolism.	Hoechst Marion Roussel Canada Research Inc. 2150 St. Elzear Blvd. West Laval, Quebec H7L 4A8
Streptokinase	Kabikinase	Management of AMI; Lysis of Pulmonary Embolism; Treatment of Deep Vein Thrombosis; Lysis of Arterial Thrombi and Emboli; Treatment of Occluded Arteriovenous Cannulae.	Pharmacia & UpJohn Inc. (Canada) 5100 Spectrum Way Mississauga, Ontario L4W 5J5

Affected products

Related AWRs