The Marketed Health Products Directorate (MHPD), Therapeutic Products Directorate (TPD)
and Biologics and Genetic Therapies Directorate (BGTD) post safety alerts, public health advisories,
press releases and other notices from industry as a service to health professionals, consumers,
and other interested parties. Although MHPD, TPD and BGTD approve therapeutic products, MHPD,
TPD and BGTD do not endorse either the product or the company. Any questions regarding product
information should be discussed with your health professional.
This is duplicated text of a letter from Novo Nordisk Canada Inc.
Contact the company for a copy of any references, attachments or enclosures. |
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PUBLIC ADVISORY
IMPORTANT SAFETY INFORMATION REGARDING GLUCONORM® (REPAGLINIDE) AND
GEMFIBROZIL AND THE RISK OF SEVERE AND PROLONGED HYPOGLYCEMIA |
July 18, 2003 - Novo Nordisk Canada Inc. is informing Canadians that the simultaneous use of
GlucoNorm® (repaglinide), an oral antidiabetic agent for type 2 diabetes, and gemfibrozil, a
lipid-lowering agent, may carry serious risks. When GlucoNorm® (repaglinide) and gemfibrozil are
taken together, patients may be at risk of severe and prolonged hypoglycemia (low blood sugar), a
condition that is potentially fatal. Patients being treated with GlucoNorm® (repaglinide) should not
start taking gemfibrozil. Patients already taking gemfibrozil should discontinue the use of this drug
before taking GlucoNorm® (repaglinide). These decisions should be discussed with your treating physician.
Recently published results of a clinical study of healthy volunteers who were given both GlucoNorm®
(repaglinide) and gemfibrozil show an adverse interaction between the two medications. When taken
together with gemfibrozil, the blood glucose-lowering effect of GlucoNorm® (repaglinide) was described as
considerably enhanced and prolonged. Novo Nordisk Canada Inc. has also received 5 reports (3 from the
U.S. and 2 from France) of severe hypoglycemia in patients who were taking GlucoNorm® (repaglinide) and
gemfibrozil simultaneously. No Canadian reports have been received.
Gemfibrozil is sold under the trade name Lopid®, as well as in generic form under other names.
Patients should check their medication packaging to determine if they are taking gemfibrozil, or ask
their pharmacist.
Patients should immediately inform their doctor if they are taking GlucoNorm® (repaglinide) and
gemfibrozil in combination and alternative combination treatment should be instituted under close
monitoring of diabetic status. They should seek medical attention immediately if they have any of
the following symptoms that may indicate possible hypoglycemia: weakness, drowsiness, confusion,
hunger, dizziness, paleness, headache, irritability, trembling, sweating, rapid heartbeat, and a cold,
clammy feeling.
This safety information has been provided to health care professionals to review with patients
prior to prescribing GlucoNorm® (repaglinide). This safety information will be added to the Canadian
Product Monograph for Gluconorm® (repaglinide).
Suspected adverse reactions arising from the concomitant use of GlucoNorm® (repaglinide) and
gemfibrozil can be reported directly to Novo Nordisk Canada Inc. at the following address:
Novo Nordisk Canada Inc.
c/o Medical and Scientific Affairs Department
2700 Matheson Blvd. East
3rd Floor, West Tower
Mississauga, Ontario
L4W 4V9
Toll: 1-800-465-4334
Tel: 905-629-4222
Any suspected adverse reactions can also be reported to:
Canadian Adverse Drug Reaction Monitoring Program (CADRMP)
Marketed Health Products Directorate
HEALTH CANADA
Address Locator: 0201C2
OTTAWA, Ontario, K1A 1B9
Tel: (613) 957-0337 or Fax: (613) 957-0335
Toll free for consumers and health professionals:
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 TPD web site or in The Canadian
Compendium of Pharmaceuticals and Specialties. |
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