The FDA is currently investigating a possible association between the diabetes drug Actos (pioglitazone) and an increased risk of bladder cancer.
Actos is commonly prescribed to treat type 2 diabetes and works by increasing the body’s sensitivity to insulin. It is usually taken once a day by mouth. By all accounts, Actos helps treat type 2 diabetes, which is undoubtedly an awful disease. But there are other diabetes options where there is no suggestion of a link to cancer. The questions that doctors are going to have to answer are whether Actos is worth the risk of cancer and whether there are other less risky options available. Ultimately, juries are also going to be asked these questions, too. They will also have to dig into the other question: what did the manufacturer of Actos know or should it have known about the association between cancer and Actos and should they have issued a recall for Actos or at least provided a warning of the risk?
The bubbling concerns about Actos culminated in a safety announcement dated June 15, 2011, wherein the FDA warned the public that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” Information about the potential risk will be added to the Warnings and Precautions label for medicines that contain Actos, and the corresponding patient Medication Guides will also be updated to reflect information on bladder cancer. In response to the FDA’s actions, the drug’s manufacturer (Takeda) has undertaken a 10-year observational study to assess the long-term risk of bladder cancer associated with the use of Actos.
The FDA’s warnings were not knee jerk: they are based on the review of 5 years of data from an ongoing, decade-long study known as PROactive (PROspective pioglitAzone Clinical Trial In macroVascular Events). The review suggested an increased risk of bladder cancer among those individuals who had the longest exposure to the drug, as well as those who received the highest cumulative dose.
Are Actos Lawsuits on the Horizon?
In what may be a harbinger of things to come in the United States, French health officials have suspended the use of Actos while Germany has recommended that Actos not be started in new patients. These actions were taken following results from a retrospective cohort study conducted in France that suggested an overall increased risk of bladder cancer among Actos users.
In contrast to the move by France to halt sales, the Japanese Health Ministry stated in a press release dated June 9, 2011, that it currently has no plans to suspend sales of Actos. Meanwhile, the London-based European Medicines Agency stated that it was reviewing all relevant safety data pertaining to Actos and bladder cancer, but was not recommending any changes to prescribing or usage in the interim. Similarly, Health Canada announced in mid-June 2011 that “in light of studies suggesting an increased risk of bladder cancer with the diabetes drug pioglitazone, as well as actions taken by other regulatory agencies, Health Canada is informing healthcare professionals and Canadians that it is undertaking a review of the drug’s status.”
I Take Actos – What Should I Do?
It is important to know that the FDA has not recalled Actos and recommends that health care providers continue to prescribe Actos according to the recommendations on the drug’s label. The FDA has, however, advised that Actos not be used in patients with active bladder cancer and to use caution when prescribing it to patients who have a prior history of bladder cancer. If you are currently taking Actos, do not stop taking your medication without consulting your doctor first. Diabetes is a very serious condition and for some people, the benefits of taking Actos may outweigh the risks.
While all vested parties await further guidance from the FDA concerning the risk of bladder cancer, it is important to understand the long list of other risks associated with Actos:
• Vision problems
• Increased bone fractures in women
• Muscle pain
• Congestive heart failure
If you are taking Actos and do not have a history of bladder cancer, you should be sure and report any of the following signs or symptoms to your doctor immediately:
• blood in the urine
• frequent urination
• pain during urination
• lower back pain
• abdominal pain
If you have a history of bladder or prostate cancer and have been taking Actos, call us at 800-553-8082 for a free evaluation of your potential Actos bladder cancer lawsuit. Alternatively, you can get a free online consultation to see whether you potentially qualify for an Actos lawsuit.