Archived – Important Safety Information – PLAS+SD PLASMA (Human) – Precision Pharma Services Inc.

Important Safety Information Regarding PLAS+®SD plasma (human), solvent detergent treated, frozen - DIN 02239911

May 16, 2002

Dear Doctor / Health care professional:

Further to the 28 March 2002 communications from Canadian Plasma Products and subsequent discussions today with Health Canada's Biologics and Genetic Therapies Directorate and Marketed Health Products Directorate, Precision Pharma Services Inc. would like to highlight the following important safety information related to use of PLAS+®SD.

• PLAS+®SD should not be used in patients undergoing liver transplant or in patients with severe liver disease and known coagulopathies;
• There have been spontaneous reports of thrombotic events including deep vein thrombosis and pulmonary embolism in patients with acute TTP undergoing plasma exchange following infusion of PLAS+®SD;
• Users are advised to carefully monitor the coagulation status of patients receiving large volumes of PLAS+®SD for evidence of thrombosis, excessive bleeding or exacerbation of disseminated intravascular coagulation (DIC).

This safety information is linked to the Important New Drug Warning which appeared in the FDA Medwatch website [NJS_FILE:6e5a40a6-dfcc-4841-89fd-157b05f7a8d6:3c0920d6-a5e7-4d2a-b77a-be7c19813c99]

Please ensure that your clients are informed and that each shipment of PLAS+®SD contains a copy of this letter.

A Dear Doctor letter was issued in October 2000, regarding reports of serious adverse events and deaths occurring in a cluster of six patients who had received intra-operative PLAS+®SD during orthotopic liver transplantation for end stage liver disease. Following the occurrence of these events, there have been additional reports of deaths due to thromboembolic complications or severe bleeding in patients with severe liver disease with known coagulopathies or in patients undergoing liver transplant, as well as serious thrombotic events occurring in patients with acute TTP undergoing plasma exchange, following infusion of PLAS+®SD.

Please note that Health Canada has not received any reports of adverse events associated with the use of PLAS+®SD in Canada. Nonetheless, health care professionals are encouraged to report any adverse events that may possibly be associated with the use of PLAS+®SD to Precision Pharma Services, Inc. or the Marketed Health Products Directorate, Health Canada at:

Precision Pharma Services, Inc.
155 Duryea Road
Melville, New York 11747
Tel: (631) 752-7314 Fax : (631) 752-7354

Should you have any questions or comments please do not hesitate to contact Precision Pharma Services, Inc. at 631-752-7314 or Canadian Plasma Products at 705-897-6481.

Sincerely,

original signed by

Ronald Guido
Vice-President, Quality Systems
Precision Pharma Services

PLAS+®SD is distributed in Canada by Canadian Plasma Products

Any suspected adverse reactions can also be reported to:

Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
Health Canada
Address Locator: 0201C2
Ottawa, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
Tel: 866 234-2345, Fax: 866 678-6789
cadrmp@hc-sc.gc.ca

The ADR Reporting Form can be found in The Canadian Compendium of Pharmaceuticals and Specialties, or on the TPD website, along with the ADR Guidelines.