HEALTH CANADA IS ADVISING HEALTH PROFESSIONALS AND PATIENTS REGARDING THE RECALL OF SPECIFIC BATCHES OF PROGLYCEM®

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2004-32 June 4, 2004 For immediate release Advisory 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 -30- 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 http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html The Adverse Reaction Reporting Form and the Adverse Reaction Guidelines can be found on the Health Canada web site or in The Canadian Compendium of Pharmaceuticals and Specialties. http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adverse_e.html http://www.hc-sc.gc.ca/hpfb-dgpsa/tpd-dpt/adr_guideline_e.html Media Inquiries: Jirina Vlk Health Canada (613) 957-2983 Public Inquiries: (613) 957-2991

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2016-12-15

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HEALTH CANADA IS ADVISING HEALTH PROFESSIONALS AND PATIENTS REGARDING THE RECALL OF SPECIFIC BATCHES OF PROGLYCEM®

News Release

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