Diabetes: Side Effects, Treatment, Blood Glucose Monitoring

by Food and Drug Administration (FDA)

(Page 4 of 5)

For patients on Rezulin, liver function tests should be done before the patient starts therapy, monthly during the first year of Rezulin therapy, and quarterly thereafter.

For patients on Actos and Avandia, liver function tests should be performed at the start of therapy, every two months during the first year of treatment, and periodically thereafter.

Symptoms suggesting liver problems include unexplained nausea, vomiting, stomach pain, tiredness, loss of appetite, dark urine or yellowing of skin (jaundice). If any of these symptoms occur, liver enzymes should be checked. If the patient develops jaundice, he or she should stop the drug therapy.

Another new class of oral blood glucose-lowering drugs, the meglitinides, was introduced in December 1997 when FDA approved Prandin (repaglinide). These drugs work like the SFUs.

Prandin is taken two, three, or four times a day usually about 15 minutes before meals. The advantage of this medicine is that, like the short-acting SFUs, it provides convenience to patients who are not on a regular eating schedule. Also, it may reduce the potential for serious hypoglycemia (low blood sugar), the most important adverse reaction of SFU therapy.

Prandin is approved for use alone or in combination with metformin.

Side Effects

Oral diabetes drugs are not without side effects. Metformin, for example, can cause serious cramps and diarrhea, and it can't be used in people with kidney problems.

Metformin is also not generally used in patients with liver dysfunction. "It should be used only in patients without major health problems and it's not for the elderly," Misbin says.

Precose is less effective but probably safer to use than metformin, he points out. Precose's one major side effect is flatulence. Precose stops, or delays, absorption of carbohydrates, causing gas. Flatulence may be reduced by beginning the drug at a low dose.

Product labeling recommends that doctors start patients on lower doses to combat the flatulence problem.

Rezulin was well-tolerated in clinical studies. The most commonly reported side effects were infection, pain and headache, but these occurred at rates comparable to those in the placebo-treated patients. Rezulin should not be used in patients with liver or heart disease. Side effects include (in addition to the most serious, liver injury) fluid retention and weight gain.

Possible side effects of Avandia are mild to moderate water retention, increased blood cholesterol levels and anemia, although in clinical studies, none of these problems led to the discontinuation of Avandia treatment.

Side effects of Actos are mild to moderate water retention and anemia.

Choosing the Right Treatment

Some diabetes experts report that when it comes to prescribing initial therapy for Type 2 diabetics, some doctors tend to follow a "treatment of laziness" — for example, prescribing SFUs if they perceive difficulties in the patient's ability to change dietary habits or lifestyle.

"Sometimes, patients with diabetes are treated with drugs when it's not really necessary," Misbin says. "Oral pills should be used in Type 2 diabetes only when diet and exercise are not effective. It's very common for overweight patients who lose weight to lower their own blood sugar levels and come off the medicines. The problem is that it's very difficult to get patients to lose weight."

So, the bottom line in diabetes control still hinges on patients' ability to manage the disease themselves. "I don't know of a chronic disease in which the person who suffers from it is so responsible for its management," says ADA president Cryer. "The patient has to become an expert regarding his or her own diabetes."

Although drug treatment makes a difference to many diabetics and their quality of life, Cryer adds that current diabetes treatments are still "not ideal." He hopes that continuing research will someday find the answer to the diabetes dilemma.

Blood Glucose Monitoring at Home

For millions of Americans with diabetes, regular home testing of blood glucose levels is critical in controlling their disease.

"The most near-normal glucose patterns you can get will have a terrific long-term impact on how well people with diabetes do," says Steven Gutman, M.D., director of the division of clinical laboratory devices in FDA's Office of Device Evaluation. But he adds, "Tight control isn't easy because it requires multiple glucose measurements."

For many years, diabetics relied on home urine glucose testing to monitor blood sugar levels. But the method was not without drawbacks. Monitoring glucose levels via the urine is problematic for several reasons: First, glucose doesn't appear in the urine until the level of glucose in the blood becomes high. Second, the point at which glucose shows up in the urine varies widely among individuals. And third, factors such as fluid or vitamin C intakes can influence test results.

About the Author

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FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.