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Women who are prescribed AVANDIA, take note: The drug poses dangers to your health in addition to the well-publicized risks of heart failure or heart attacks (see accompanying article) – it could increase the chances that you fracture a bone.
The Food and Drug Administration (FDA) issued warnings earlier this year about the increased risk of upper arm, hand and foot fractures in women who use the type-2 diabetes drug AVANDIA (rosiglitazone) or the related diabetes drug ACTOS...
Women who are prescribed AVANDIA, take note: The drug poses dangers to your health in addition to the well-publicized risks of heart failure or heart attacks (see accompanying article) – it could increase the chances that you fracture a bone.
The Food and Drug Administration (FDA) issued warnings earlier this year about the increased risk of upper arm, hand and foot fractures in women who use the type-2 diabetes drug AVANDIA (rosiglitazone) or the related diabetes drug ACTOS (pioglitazone).
In recent years, Public Citizen has warned that these drugs cause serious side effects. Public Citizen has listed both AVANDIA and ACTOS as “Do Not Use” drugs since 2004 because they are only marginally effective at controlling type-2 diabetes and carry with them the possibility of serious side effects, including the ones outlined by the FDA. Other side effects could include weight gain, fluid retention, liver toxicity, anemia and vision disturbances (see Worst Pills, Best Pills News December 2006, April 2006 and September 2003).
AVANDIA (rosiglitazone)
On Feb. 20, the FDA posted a warning to health care providers on its Web site reporting the results of two large clinical trials that found that AVANDIA increased the frequency of upper arm, hand and foot fractures in females compared to two older diabetes drugs – metformin (GLUCOPHAGE) and glyburide (DIABETA, GLYNASE, MICRONASE).
The first study, which involved 4,360 men and women with an average age of about 58, compared the effects of AVANDIA, metformin and glyburide on blood-sugar control in newly diagnosed diabetics. Patients were randomized to their respective study groups and studied between four and six years.
The table accompanying this article summarizes the main fracture results from the first trial. In those taking rosiglitazone, there was no difference in fracture rates in men. However, in women, there was nearly a three-fold increase in fracture rates.
Main Fracture Results from the First Trial
| Patients Who Experienced Fractures |
AVANDIA (Rosiglitazone) |
GLUCOPHAGE (Metformin) |
GLYNASE, MICRONASE (Glyburide) |
|---|---|---|---|
| Females: number (%) | 60 (9.30%) | 30 (5.09%) | 21 (3.47%) |
| Males: number (%) | 32 (3.95%) | 29 (3.36%) | 28 (3.35%) |
The increase in the percentage of women experiencing a fracture in patients taking AVANDIA compared to metformin was 4.21 percent; there was a 5.83 percent increase in fractures in women taking AVANDIA compared to women taking glyburide.
The fracture results of the trial were confirmed by an interim analysis of another long-term randomized controlled trial of AVANDIA. While the FDA did use the second trial to bolster its warning, the trial’s final results are not expected to be available until 2009.
These results also apply to other drugs containing AVANDIA’s active ingredient, rosiglitazone: the combination of rosiglitazone and metformin (AVANDAMET) and the combination of rosiglitazone and glimepiride (AVANDARYL).
ACTOS (pioglitazone)
Following the rosiglitazone warning in February, the FDA posted another warning for health care providers in March about an increase in fractures, this time for women taking the closely related drug ACTOS.
An analysis of its ACTOS clinical trial database by ACTOS manufacturer Takeda Pharmaceuticals found that there were about two fractures out of every 100 women taking ACTOS for one year, compared to about one fracture out of every 100 women using other diabetes drugs. There was no increased risk of fracture identified in men.
Takeda stated that the majority of fractures observed in female patients who received ACTOS were in the forearm, hand and wrist or foot, ankle, fibula (smaller of two bones between the knee and ankle) and tibia (larger of the two bones between the knee and ankle).
The warning also applies to other drugs containing ACTOS’ active ingredient, pioglitazone: the combination of pioglitazone and metformin (ACTOPLUS MET) and the combination of pioglitazone and glimepiride (DUETACT).
What You Can Do
You should not use AVANDIA or ACTOS for the management of type-2 diabetes. This disease is preventable by lifestyle modification including diet and increasing exercise (see Worst Pills, Best Pills December 2006). Other drugs approved for type-2 diabetes (such as glyburide or glipizide) are equally or more effective than AVANDIA or ACTOS, relatively safer and less expensive.
