The U.S. Food and Drug Administration (FDA) has recently found that, on top of risks of heart disease, Actos may also increase the risk of bladder cancer in patients who use the drug for longer than a year. The FDA gave their warning just days after Actos was pulled from German and French markets due to similar concerns.
Actos is a drug used to control blood sugar and increase insulin sensitivity in adults with Type 2 diabetes. It is a member of the thiazolidinedione (TZD) family of drugs that has been found effective for treating diabetes patients. However, the only other member of this drug family, Avandia (rosiglitazone) was pulled from pharmacy shelves in May due to its association with increased risk of heart attack. TZD drugs are associated with many other risks, including:
- Bone fractures
- Congestive heart failure
- Fluid retention problems
Many doctors are now shying away from this class of drugs altogether.
The FDA Study
Since last September, the FDA has been monitoring the effects of Actos on bladder cancer in diabetes patients. So far, the study – which involves over 193,000 patients – has shown that those taking Actos for longer than one year had a 40% higher chance of developing bladder cancer. A recent study from France has also shown that risk of cancer increases as dosage and time increase after one year on the drug. The FDA will continue the study until they have 10 years’ worth of data, which will enable them to make more conclusive statements.
Risks vs. Rewards
Though Actos’s maker, Takeda Pharmaceuticals, remains confident of its benefits to those suffering from Type 2 diabetes, the FDA asks patients and doctors to consider the risks against the benefits of taking Actos.
The FDA has not yet included Actos in any pharmaceutical drug recall because it is currently the only drug on the market that directly influences insulin resistance, and it has proved highly effective when combined with other drugs, such as metaformin (found in Actoplus Met and Actoplus Med XR) and glimepiride (found in Duetact).
However, the benefits of controlled diabetes may not be worth the risk of bladder cancer, heart problems, and other conditions. Patients who currently have bladder cancer, or have had it in the past are advised not to use the drug, and diabetes patients should alert their doctor immediately if they experience bladder cancer symptoms such as:
- Urgent/repeated need to urinate
- Pain while urinating
- Blood in urine
- Lower back/abdomen pain
If you or a family member has developed bladder cancer or another condition while taking Actos or Avandia, the pharmaceutical company or even your doctor could be held responsible for your disease. You may be able to claim compensation for medical malpractice or product liability. To find out more about Actos and bladder cancer, please contact an experienced pharmaceutical injury attorney for a personal consultation.