TreatmentUpdate79 - Vol. 7, No. 9; July 1997
Sean Hosein
The American Food and Drug Administration (FDA) has warned doctors in the US about the possibility of protease inhibitors causing a new side effect -- diabetes. (Further information on diabetes appears several paragraphs below) This side effect has been noted in people taking all 4 protease inhibitors (PI) approved for use in the US:
* saquinavir (old version)
The risk of developing diabetes appears to be low -- less than 1%. So far, of the 83 cases reported to the FDA, only 1/3 needed to be hospitalized. On average, it took about 76 days of PI use for symptoms of diabetes to appear. Half of the 83 people needed to stop taking PIs in order for their diabetes to clear, although some affected people continued to take oral anti-diabetes drugs.
Should people stop using protease inhibitors?
Although diabetes is a serious condition, PHAs using PIs should not suddenly stop taking them because of this possible side effect. It is important to remember that the risk of developing diabetes is less than 1%. Moreover, people who did develop diabetes while taking PIs were able to control it with insulin or oral drugs. The FDA believes that the benefit from PIs outweighs the risk of developing diabetes. They suggest that PHAs who have diabetes (not caused by PIs) and are taking or considering using PIs should discuss the benefits and risks of using this therapy with their doctor(s).
Diabetes
Diabetes is a disease that occurs when the body is unable to properly make use of sugar (glucose) in the blood because there is not enough of the hormone insulin present or because the insulin being made does not work. Thus the amount of sugar in the blood becomes higher than normal, a condition called hyperglycemia. When the amount of blood sugar becomes dangerously high, people can develop "nausea, vomiting...stomach pain and rapid breathing." Other signs include "fruity breath odour, a rapid and weak pulse and low blood pressure. If the person is not given [liquids] and insulin right away [they can go into a coma and die]."
Checking up on blood sugar
The World Health Organization and the Centres for Disease Control (CDC) have endorsed new guidelines for diagnosing diabetes. Specifically, if a person's blood sugar "reaches 126 mg/dL or higher" on two tests done on two different days, then the person has diabetes. The normal reading should be below 110 mg/dL and the range between 110-125 is now considered a "danger zone" -- where the body's ability to process glucose is...impaired."
REFERENCES:
1. Lumpkin MM. Reports of diabetes and hyperglycemia in patients receiving protease inhibitors for the treatment of Human Immunodeficiency Virus (HIV). FDA Public Health Advisory 11 June 1997.
2. Anonymous. Health Advisory for newest class of AIDS drugs. FDA Talk Paper 11 June 1997.
3. Grady D. New guidelines for diagnosing diabetes. New York Times 24 June, 1997.
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