Actos (pioglitazone), a diabetes medication is being reviewed by the FDA (Food and Drug Administration) after it received a long-term observational study which evaluated the risk of bladder cancer. The preliminary results of the 10-year observational long-term study are based on five-year data gathered by Takeda Pharmaceuticals North America Inc., San Diego.
Pioglitazone is used along with diet and exercise to control blood sugar or improve control of blood sugar in patients with Type 2 Diabetes mellitus. Approximately 20 in every 100,000 Americans per year develop bladder cancer, which is thought to be higher in people with diabetes. It is a PPAR (peroxisome proliferator-activated receptor) agonists. Avandia (rosiglitazone) is also a PPAR agonist.
Early results do not show any overall link between Actos exposure and bladder cancer risk. However, patients with the longest exposure to the medications, as well as those with the drug’s highest cumulate dose, did have some risk.
The FDA says there is an ongoing review, and that it has come to no conclusion yet regarding any association between Actos exposure and bladder cancer risk.
The FDA says it has no clinical data linking Avandia with bladder cancer risk. The only PPAR agonists on the market are Actos (pioglitazone) and Avandia (rosiglitazone).
Anybody who is currently taking Actos and is concerned should talk to their health care professional, the FDA recommends. They should only stop taking the medication if their doctor tells them to.
Actos was approved in 1999 as an adjunct to exercise and diet to improve glycemic control in adults with Type 2 Diabetes. Across the approved doses Actos reduced HbA1c compared to placebo by an average of 1.5%.
Takeda makes Actos, and GlaxoSmithkline makes Avandia.
After concerns of a raised risk of heart attack (but not death), in July, 2010 an FDA advisory panel recommended that Avandia remain on the market, but with tightened controls.
Source: Food and Drug Administration
Written by Christian Nordqvist