Octreotide Acetate Omega - Advisories, Warnings and Recalls for Health Professionals

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Contact : DCVIU UVCEM

Health Canada Endorsed Important Safety Information on Octreotide Acetate Omega

January 26, 2006

Subject: URGENT - Product Recall Notice
Octreotide Acetate Omega 500 μg/mL
DIN: 02248641
LOT #: 5J970

Dear Health Care Professionals,

RISK OF SERIOUS HARM AND/OR DEATH WITH POTENTIAL IV/SC ADMINISTRATION OF FLUPHENAZINE DUE TO MISLABELLED OCTREOTIDE VIALS

Omega Laboratories, Ltd has initiated a Class I recall of Octreotide Acetate Omega 500 μg/mL. Some vials of Octreotide Acetate Omega 500 μg/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 subcutaneoulsy 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 we want to inform you as health care professionals involved in the treatment of patients receiving this medication.

Pharmacists: Please notify all physicians that have prescribed this product to patients of the information related to this recall within 24 hours. Please confirm by fax to Omega Laboratories Ltd. at (514) 339-1407 that all physicians that have prescribed this product have been contacted and informed of the product recall.

In addition, please contact patients that have been prescribed this product and instruct them 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.

Physicians: Health Canada urges 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 would like to provide you with important safety information for Fluphenazine (Fluphenazine decanoate injection), regarding possible signs, symptoms and treatment of overdose. 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 i.v. 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, i.v. magnesium sulfate and/or a pacemaker should be used. Extrapyramidal reactions may be treated with i.v. 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 μg/mL (Lot 5J970) should be reported to Omega Laboratories Ltd. or Health Canada at the following addresses:

Sincerely,

original signed by

Madeleine Fall
Laboratoires Oméga, Ltée.