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On Oct. 30, Public Citizen formally petitioned the Food and Drug Administration (FDA) to immediately ban the dangerous diabetes drug rosiglitazone (AVANDIA), after our new research found that the drug causes liver failure in addition to many other previously known kinds of serious toxicity. We have warned Worst Pills, Best Pills readers not to use the drug since January 2005.
Public Citizen researchers identified 14 cases of liver failure — including 12 deaths — in the FDA’s Adverse Events...
On Oct. 30, Public Citizen formally petitioned the Food and Drug Administration (FDA) to immediately ban the dangerous diabetes drug rosiglitazone (AVANDIA), after our new research found that the drug causes liver failure in addition to many other previously known kinds of serious toxicity. We have warned Worst Pills, Best Pills readers not to use the drug since January 2005.
Public Citizen researchers identified 14 cases of liver failure — including 12 deaths — in the FDA’s Adverse Events Reporting System (AERS) database. AERS is used to collect information about side effects experienced once a drug has been approved by the FDA and is available to consumers.
The petition was released just as an unprecedented announcement by both the American Diabetes Association and the European Association for the Study of Diabetes appeared in a pre-publication consensus article on treatment of diabetes. The two groups concluded that for the treatment of diabetes, “given that other [treatment] options are now recommended, the consensus group members unanimously advised against using rosiglitazone.“ [Emphasis added]
“The scientific consensus against Avandia is overwhelming,” said Dr. Sidney Wolfe, director of Public Citizen’s Health Research Group. “The timing of these findings should give the FDA the momentum it needs to act swiftly to prevent further needless deaths and health damage by banning this drug.”
In 2000, the FDA banned a similar drug to rosiglitazone, troglitazone (REZULIN), because it was linked to liver failure. Public Citizen had asked the FDA to ban troglitazone as well.
Drug causes multiple toxicities
Although liver failure with rosiglitazone is not as frequent as with troglitazone, there are other kinds of serious, often life-threatening toxicities with rosiglitazone that have now been identified. These include evidence of a 30 to 40 percent increased risk of heart attacks, a doubling of the risk of new onset of heart failure, a doubling of the occurrence of bone fractures, increased incidence of anemia and a large number of reports of macular (retinal) edema with vision loss.
The clear evidence for this wide range of serious side effects is compounded by the accompanying lack of evidence of any clinical benefit, compared to other approved drugs for diabetes such as metformin (GLUCOPHAGE), insulin and sulfonylureas (such as glipizide [GLUCOTROL]). Those drugs actually decrease the incidence of heart attacks and all-cause mortality.
As can be seen in the chart that accompanies this article, prescriptions filled for rosiglitazone have decreased sharply following the
The peak number of rosiglitazone prescriptions was in 2006 with 13.2 million prescriptions filled in the
The full petition is available online here.
What You Can Do
If you are currently using rosiglitazone, ask your doctor to switch to a safer, more effective drug. These include metformin, sulfonylurea drugs such as glipizide or, possibly, insulin.
Do not use pioglitazone (ACTOS), a drug in the same family as rosiglitazone. Although it does not increase the risk of heart attacks, it shares most of the other toxicities with rosiglitazone and the American Diabetes Association does not consider it a first-line drug for treating diabetes.
