rosiglitazone (cont.)
A review of the studies of rosiglitazone led the FDA to conclude that the medication might increase the risk of heart attacks and angina, but left the association as inconclusive. Additionally, there isn't enough evidence that the risk of heart attack and angina is any greater with rosiglitazone than with other oral medicines used in the treatment of diabetes.
Since troglitazone, a related drug, was associated with liver injury, it is
recommended that liver tests be obtained before starting therapy and
periodically thereafter. Side effects which may suggest liver injury include
unexplained nausea, vomiting, abdominal pain, fatigue, anorexia (loss of
appetite), or dark urine.
Rosiglitazone may cause ovulation in premenopausal women who have stopped
ovulating because they are resistant to insulin. Rosiglitazone may improve
insulin sensitivity sufficiently to cause ovulation. Therefore, there is the
potential for rosiglitazone to lead to pregnancy.
Studies testing rosiglitazone excluded New York Heart Association Class III
and IV patients who have more serious heart disease. Therefore, it is not known
how these classes of patients will respond to treatment. The concern is that
fluid accumulation may lead to heart failure in these patients.
Rosiglitazone alone or combined with metformin has demonstrated various
effects on blood lipids. Studies have shown elevated total and low-density
cholesterol (LDL) levels within the first two months of rosiglitazone therapy
with or without metformin, while high-density cholesterol (HDL) levels increase
and free fatty acids decrease with continued therapy.
Two large studies have shown increased upper and lower extremity fractures in
women taking rosiglitazone.
Reference: FDA Prescribing Information
Last Editorial Review: 11/19/2007
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