Warning
1998-78
October 30, 1998
Warning not to use APO-PREDNISONE 1mg tablets OTTAWA - Health Canada is advising Canadians not to use APO-PREDNISONE 1mg tablets manufactured by Apotex as the drug dispensed by the pharmacist may actually be APO-PRAZO 5mg Tablets. The product was inadvertently mislabelled. The Therapeutic Products Programme of Health Canada has been advised by Apotex Inc. that a single bottle of 100 tablets of Lot Number CD230 of Apo-Prednisone 1mg tablets contains Apo-Prazo (Prazosin hydrochloride). It is possible that one or more such bottles may be in pharmacies. This product would be dispensed into prescription-size vials by a pharmacist.
Apo-Prazo is prescribed for the treatment of hypertension. Symptoms associated with the inappropriate use of Apo-Prazo include dizziness, lightheadedness, fainting and sudden loss of consciousness. A dose of 5 mg or higher of Apo-Prazo in a person not requiring this drug may present a serious health hazard. Apo-Prednisone is a corticosteroid which is widely used. For those patients prescribed Apo-Prednisone, there should be no acute effects from missing an Apo-Prednisone dose for a short period of time. Both of these products are available only on prescription. Health Canada is advising that anyone currently prescribed Apo-Prednisone 1mg tablets should check their prescription to determine that they have round, white tablets with APO/1 imprinted on one side of the tablet. If the Apo-Prednisone tablets are diamond-shaped, white tablets with APO/P5 imprinted on one side of the tablet, consumers should stop using them immediately and should contact their physician. If consumers are not sure about their tablets, they can consult their pharmacist. Health Canada is continuing its investigation into these products.
Information:
Siddika Mithani
(613) 292-8712 (cellular)
(613) 566-8345 (pager)
(613) 941-0776 (office, after November 2/98)
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