Advisory
2004-32
June 4, 2004
For immediate release
Health Canada is advising health professionals and patients regarding the recall of specific batches
of Proglycem®
OTTAWA - Health Canada is advising health professionals and patients regarding
the recall of specific lots of Proglycem® Suspension by Schering Canada Inc. due to elevated levels
of the active ingredient, Diazoxide. Proglycem® Suspension is an oral liquid medication prescribed
by physicians for the treatment of low blood sugars resulting from rare conditions associated with
abnormally increased insulin levels. The affected lots of Proglycem® Suspension that are being recalled
may cause severe reactions or death as a result of increasing blood sugars above normal ranges.
The affected lots are: 2-GJAB-02, 3-GJAB-01, 3-GJAB-02A.
A letter was sent to health professionals by Schering Canada Inc on June 1, 2004, advising them
of this potential problem. As a precaution, Health Canada is advising patients who use this drug
to monitor their blood or urine sugars very closely and to contact their physicians for further instructions.
Patients are also advised to be aware of the symptoms from excessively high blood sugars and to
contact a health professional immediately if any of these symptoms are experienced. Symptoms of excessively
high blood sugars include:
- thirst
- excessive urination
- nausea
- vomiting
- abdominal pain
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Any suspected adverse reaction 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 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
cadrmp@hc-sc.gc.ca
For other inquiries: please refer to contact information.
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.
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Photograph of product
Media Inquiries:
Jirina Vlk
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
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