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February 21, 2011
Here’s an important safety update about the diabetes medication pioglitazone (brand name: Actos), one of the 20 most prescribed drugs with 12 million prescriptions filled in 2009.
On September 17, 2010, the Food and Drug Administration (FDA) issued a safety announcement stating that it is reviewing data from a 10-year study of the type-2 diabetes drug pioglitazone for its association with an increased risk of malignant bladder cancer. The study was conducted...
February 21, 2011
Here’s an important safety update about the diabetes medication pioglitazone (brand name: Actos), one of the 20 most prescribed drugs with 12 million prescriptions filled in 2009.
On September 17, 2010, the Food and Drug Administration (FDA) issued a safety announcement stating that it is reviewing data from a 10-year study of the type-2 diabetes drug pioglitazone for its association with an increased risk of malignant bladder cancer. The study was conducted because of the occurrence of bladder tumors in rats given a dose of pioglitazone approximately equal to that of the 30- and 45-mg-per-day doses taken by people.
The agency has already found evidence to suggest an increased risk of bladder cancer in patients with the longest exposure to pioglitazone and those taking the highest cumulative dose of the drug. The FDA’s announcement stated that “findings from studies in animals and humans suggest this is a potential safety risk that needs further study.”
However, at this time the FDA has not concluded a definite relationship between pioglitazone and bladder cancer, something that is very hard to do using data from epidemiological studies. Its review is ongoing, and the agency will update the public when it has additional information. Patients should report any side effects from pioglitazone to the FDA MedWatch program.
What You Should Do
You should not use pioglitazone.
In addition to possibly causing bladder cancer, the medication may not be as effective as other drugs for diabetes. It also has been found to cause liver damage, weight gain, anemia and heart failure. Also, do not use the similar but even more dangerous diabetes medication rosiglitazone (brand name: Avandia), which was banned in Europe, but due to FDA negligence is still available in the United States.
Diet and exercise are the safest and most effective ways to treat type-2 diabetes. If lifestyle modifications do not work, the next-safest option is insulin injections, followed by use of the alternative diabetes pills. The least dangerous diabetes medications that we have reviewed include glimepiride (brand name: Amaryl), glipizide (brand name: Glucotrol), glyburide (brand names: Diabeta, Glynase, Micronase), tolazamide (brand name: Tolinase), tolbutamide (brand name: Orinase), and metformin (brand name: Glucophage).
Do not stop taking any medication without first consulting your physician.
