Warning

2006-03
January 26, 2006
For immediate release

Health Canada warns consumers of recall of Octreotide Acetate Omega 500 µg/mL due to possible mislabelling

OTTAWA - Health Canada is warning consumers not to use the prescription drug Octreotide Acetate Omega 500 µg/mL from lot number 5J970 as some vials from this lot may mistakenly contain the antipsychotic drug fluphenazine.

Accidental administration of fluphenazine can have serious health consequences including coma and death. Consumers who have used Octreotide Acetate Omega from this lot and have experienced any of the symptoms listed below or are concerned about their health should seek medical attention immediately. The product should be returned to the place of purchase.

A recall of this lot of Octreotide Acetate Omega has been initiated by Omega Laboratories Ltd. of Montreal. Octreotide Acetate Omega is packaged in boxes of five vials. Each 2 mL glass, amber-coloured vial contains a 1 mL dose. The product is distributed across Canada by Mayne Pharma Canada of Montreal. The eight-digit Drug Identification Number (02248641) and the lot number can be found on the vial label.

Octreotide Acetate can be administered under the skin by patients at home to treat symptoms created by hormone-secreting tumours. It can also be administered intravenously by medical professionals.

Fluphenazine is used to treat schizophrenia and psychotic symptoms such as hallucinations, delusions and hostility.

Symptoms of fluphenazine overdosage include low blood pressure, drowsiness that may progress to coma, and severe reactions such as muscle stiffness, tremors and involuntary movements. Both high and low body temperature have been reported. Other symptoms include: high fever, a state of confusion or reduced consciousness, irregular heartbeat, seizures, respiratory and/or cardiovascular collapse.

Patients who do not receive Octreotide as prescribed could experience various symptoms from their underlying condition.

A letter has been sent by the manufacturer to health professionals, wholesalers and pharmacists alerting them to the recall and informing them of the symptoms and treatment of fluphenazine overdosage.

To date, no adverse reactions from the use of this product has been reported in Canada. To report a suspected adverse reaction, please contact the Canadian Adverse Drug Reaction Monitoring Program (CADRMP) of Health Canada by one of the following methods:
Telephone: 866-234-2345
Facsimile: 866-678-6789

CADRMP
Marketed Health Products Directorate
Health Protection Building, Tunney's Pasture, AL 0701C
Email: cadrmp@hc-sc.gc.ca

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Media Enquiries:
Jirina Vlk
Health Canada
(613) 957-2988

Public Enquiries:
(613) 957-2991
1-866 225-0709