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Risk of Serious Harm and/or Death With Potential IV/SC Administration of Fluphenazine Due to Mislabelled Octreotide Vials

OTTAWA, CANADA -- February 15, 2006-- Omega Laboratories, Ltd has initiated a Class I recall of Octreotide Acetate Omega 500 mcg/mL. Some vials of Octreotide Acetate Omega 500 mcg/mL Lot 5J970 might contain fluphenazine 100 mg/mL as a result of a labelling error during the manufacturing process.

Fluphenazine is an antipsychotic medication used to treat schizophrenia and psychotic symptoms such as hallucinations, delusions, and hostility. Fluphenazine is intended to be administered intramuscularly or subcutaneously and should not be administered intravenously as is intended for Octreotide Acetate.

This product recall is being initiated with all distributors, wholesalers and direct pharmacy accounts that have received the affected lot. Additionally, the company informed health care professionals involved in the treatment of patients receiving this medication.

In its statement, Omega Laboratories also asked pharmacists to notify all physicians that have prescribed this product to patients of the information related to this recall within 24 hours, and to confirm to the company that all physicians that have prescribed this product have been contacted and informed of the product recall.

Patients that have been prescribed this product should also be notified of the recall and should be instructed to check their unused vials to ensure they are not in possession of product from the affected lot. Those in possession of affected product or those who are unsure if they are in possession of affected product should return the product immediately to their pharmacy for appropriate identification and replacement.

Health Canada urged prescribing physicians to immediately contact their patients currently taking this product to evaluate them for possible fluphenazine overdose as described below.

After discussion with Health Canada, Omega Laboratories, Ltd also provided important safety information regarding possible signs, symptoms and treatment of overdose associated with fluphenazine (fluphenazine decanoate injection). Further information may be obtained from your Regional Poison Control Centre.

Symptoms of Fluphenazine Overdose
Symptoms of fluphenazine overdosage are an extension of its pharmacologic action. The primary symptoms observed are severe extrapyramidal reactions, hypotension and sedation. Mild or early intoxication may cause restlessness, confusion and excitement. CNS sedation may progress to coma. Disturbed temperature regulation can occur; both hypo- and hyperthermia have been reported. Neuroleptic malignant syndrome can occur in overdose or with therapeutic doses. Other symptoms may include: tachycardia, cardiac arrhythmias, seizures, miosis, and respiratory and/or vasomotor collapse and/or death.

Treatment of Fluphenazine Overdose
Initial hospitalization maybe required in cases of larger overdoses. Patients experiencing a fluphenazine overdose may require respiratory and hemodynamic support. This may include intubation, ventilation, boluses of isotonic IV fluids, and inotropic support. Patients who seize should be treated with benzodiazepines. Ventricular arrhythmias are uncommon, and should be treated with boluses of sodium bicarbonate as well as conventional anti-arrhythmics such as lidocaine. In the rare patient with torsades de pointes, IV magnesium sulfate and/or a pacemaker should be used. Extrapyramidal reactions may be treated with IV benztropine or diphenhydramine. Close medical supervision should be maintained throughout the duration of drug action.

The identification, characterization and management of marketed health product-related adverse reactions are dependent on the active participation of health care professionals in adverse reaction reporting programmes. Any occurrences of suspected adverse reactions in patients receiving Octreotide Acetate Omega 500 mcg/mL (Lot 5J970) should be reported to Omega Laboratories Ltd. or Health Canada at the following addresses:

Omega Laboratories, Ltd.
11 177 Hamon
Montreal, Quebec
H3M 3E4
Tel: (514) 335-0310
or 1-800-268-2741
Fax: (514) 339-1407

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

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.

For other inquiries related to this communication, please contact Health Canada at:
Drug Compliance Verification & Investigation Unit (DCVIU)
E-mail: DCVIU_UVCEM@hc-sc.gc.ca
Telephone: (613) 941-3967
Fax: (613) 952-9805


SOURCE: Omega Laboratories, Ltd., and Health Canada

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