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Reports of Diabetes and Hyperglycemia in Patients Receiving Protease Inhibitors for the Treatment of Human Immunodeficiency Virus (HIV)

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Contact: BGIVD_enquiries

July 4, 1997

The Therapeutic Products Directorate (TPD) has been informed of recent reports of new onset diabetes mellitus, hyperglycemia, or exacerbation of existing diabetes mellitus occurring in HIV-infected patients receiving protease inhibitors. While about 8 cases have been reported in Canada, TPD is aware of approximately 152 cases worldwide. The time of onset was usually several months after initiation of protease inhibitor therapy, but occurred as early as four days after commencing therapy. Diabetic ketoacidosis has occurred only rarely.

At present, there is no conclusive evidence to establish a causal relationship between protease inhibitor therapy and the incidence of diabetes and hyperglycemia.

Many of the reports occurred in patients with confounding medical conditions, some of which required therapy with agents that have been associated with the development of diabetes mellitus or hyperglycemia.

Patients with HIV infection who are currently using protease inhibitor therapy should not necessarily discontinue therapy, but should instead consult with their health care providers if they have concerns. Treatment of this complication is a matter of clinical judgement. Physicians should weigh the severity of the diabetes and hyperglycemia against the known benefits of protease inhibitor therapy for HIV disease.

In Canada at present, there are three marketed protease inhibitors, Invirase (saquinavir mesylate), Norvir (ritonavir), and Crixivan (indinavir sulfate). A fourth, Viracept (nelfinavir) is currently under review.

Health Canada will be monitoring the situation closely as further information becomes available.

Questions about specific drugs should be addressed to the manufacturers of that drug. Health care professionals are encouraged to report any cases of diabetes and hyperglycemia, or any other serious toxicity associated with the use of protease inhibitors, to the manufacturer and directly to the Canadian Adverse Drug Reaction Monitoring Program (613) 957-0335, Therapeutic Products Directorate, Health Canada, Ottawa, Ontario.