Medications and Drugs
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Avandia - An Endocrinologist's Perspective
Medical Author: Ruchi Mathur, MD, FRCP(C)
Medical Editor: Melissa Conrad Stöppler, MD
 Steven Nissan and colleagues released an article in the New England Journal
of Medicine recently that reviewed the relationship between rosiglitazone
(Avandia) and the risk of heart attack and death from cardiovascular causes.
Rosiglitazone is one drug in a class of insulin sensitizers known as
thiazolidinediones, or TZDs. This class of drugs is commonly prescribed for the
treatment of type 2 diabetes and for insulin resistance. The authors of the recent paper reviewed 42 published and unpublished randomized clinical trials, studying patients taking rosiglitazone for a minimum of 24 weeks.
Their
analysis found a significantly increased risk for heart attack and an even
higher risk for overall cardiovascular death from all causes.
While this is of concern, it is important to realize these data were analyzed
in a retrospective fashion...
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Pharmacy Author: Emmanuel Saltiel, PharmD, FASHP, FCCP
Pharmacy and Medical Editor: Jay W. Marks, MD
GENERIC NAME: rosiglitazone maleate
BRAND NAME: Avandia
DRUG CLASS AND MECHANISM: Rosiglitazone is an oral drug that reduces
the amount of sugar (glucose) in the blood. It is used for treating patients
with type 2 diabetes and is in a class of anti-diabetic drugs called
thiazolidinediones. The other member of this class is pioglitazone (Actos).
Insulin is a hormone produced by the pancreas that is important for controlling
the levels of glucose in the blood. Insulin stimulates the cells of the body to
remove glucose from the blood and thereby lowers the level of glucose in the
blood. Patients with type II diabetes cannot make enough insulin. As a result,
the cells in their bodies do not remove enough glucose from the blood, and the
level of glucose rises. Rosiglitazone often is referred to as an "insulin
sensitizer" because it attaches to the insulin receptors on cells throughout the
body and causes the cells to become more sensitive (more responsive) to insulin
and remove more glucose from the blood. At least some insulin must be produced
by the pancreas in order for rosiglitazone to work). Rosiglitazone was approved
by the FDA on May 28, 1999.
GENERIC AVAILABLE: No
PRESCRIPTION: Yes
PREPARATIONS: Tablets: 2, 4, and 8 mg.
STORAGE: Tablets should be kept at room temperature, 15-30 C
(59-86 F).
PRESCRIBED FOR: Rosiglitazone, combined with diet, exercise, weight
control, and cessation of smoking is used for treating type II diabetes.
Rosiglitazone may be used alone or in combination with other types of
anti-diabetic drugs such as metformin
(Glucophage) or sulfonylureas as well as insulin. Since
it requires naturally-secreted insulin to be effective, rosiglitazone is not
recommended for use in type I diabetes where the amount of insulin is very low
or absent.
DOSING: Rosiglitazone may be taken once or twice daily, with or
without meals. Daily doses range from 4 to 8 mg either with or without other
antidiabetic medications. Studies do not demonstrate additional effects when
more than 8mg per day are taken.
DRUG INTERACTIONS: Rifampin decreases the blood concentration of
rosiglitazone by increasing its breakdown in the liver. Therefore, use of
rifampin may decrease the effect of rosiglitazone.
Gemfibrozil (Lopid) increases the concentration of rosiglitazone in the blood by
reducing its breakdown. Therefore, rosiglitazone may increase the side effects
of rosiglitazone.
PREGNANCY: There are no adequate studies of rosiglitazone in pregnant
women.
NURSING MOTHERS: It is unknown if rosiglitazone is secreted in breast
milk. Therefore, the safety of rosiglitazone to nursing infants also is unknown.
SIDE EFFECTS AND PRECAUTIONS: The most common side effects seen with
rosiglitazone alone or in combination with metformin are upper respiratory tract
infection, headache, back pain, hyperglycemia, fatigue, sinusitis, diarrhea, and
hypoglycemia. Rosiglitazone has been shown to cause mild to moderate
accumulation of fluid (edema) and can lead to heart failure. Patients who already have heart failure may develop worsening symptoms with rosiglitazone. In addition, anemia
may occur with rosiglitazone alone or combined with metformin. Rosiglitazone
also causes increasing amounts of weight gain with increasing doses.
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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