Warning
2004-64
December 3, 2004
For immediate release
Health Canada warns Canadians that certain lots of a sedative (Novo-Lorazem) may contain pills
of a different drug
OTTAWA - Health Canada is advising consumers taking the sedative Novo-Lorazem to
check their bottles for pills of a different shape and size, after a report alerted Health Canada
to the presence of Novo-Glyburide (an oral hypoglycemic) pills in certain Novo-Lorazem bottles.
Novo-Glyburide is generally prescribed to diabetics to lower blood sugar. The use of this drug by
non-diabetics or by diabetics already taking other medications used to lower blood sugar, might severely
lower blood sugar, which in rare cases could result in coma and/or death.
Novo-Lorazem (0.5mg) is a generic prescription sedative, manufactured by NovoPharm Limited and distributed
throughout Canada. It is often prescribed for insomnia and for the treatment of symptoms associated
with chemotherapy. The Drug Identification Number (DIN) for the product is 00711101, and the lot
numbers affected are: 132932A and 132932B. The expiry date for these lots is October 2005.
There are significant differences in shape and marking between Novo-Lorazem and Novo-Glyburide pills.
The primary difference is the shape and size of the tablets. Novo-Lorazem 0.5mg
tablets are white, round, flat-face tablets with "N" engraved on one side, and "0.5" engraved
on the other. Novo-Glyburide tablets are white, capsule-shaped tablets with "N/N" engraved
on one side and "5" engraved on the other. Novo-Glyburide tablets are also twice the size of
Novo-Lorazem tablets. Below is a photograph of both Novo-Lorazem and Novo-Glyburide to help consumers
distinguish between the two drugs.
Consumers taking Novo-Lorazem are advised to check their bottles for capsule-shaped tablets with "N/N" engraved
on one side. Tablets found to meet this description should not be consumed and the
bottle should be returned to the pharmacy. Patients who suspect they may have consumed these tablets
should contact their physician.
The affected lots are being recalled by the manufacturer, Novopharm Limited. The company is also
working with Health Canada to identify and address the cause of the problem. Health Canada was first
informed of the incident by the manufacturer following complaints received from a hospital and a
pharmacy. In both those cases, the pharmacist noted the differently-shaped pills and they were not
dispensed.
Health Canada is currently investigating whether there have been any adverse events reported in
association with this incident. However, as of this time, no other complaints have been received
by Health Canada. Health Canada continues to oversee the effectiveness of the recall.
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Media Inquiries:
Margot Geduld
Health Canada
(613) 957-2983
Public Inquiries:
(613) 957-2991
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