Questions Over Actos and Bladder Cancer Nothing New

Washington, DCWhen the US Food and Drug Administration (FDA) announced in September that they had Actos under review for a potential link to bladder cancer and other Actos side effects, patients suffering from Type 2 diabetes might be forgiven for wondering just how many more shoes were available to drop. Ever since Avandia was deemed to be high risk, scores of doctors switched their Type 2 diabetes patients to Actos given the belief it was the safer alternative.

But is it? Not only is Actos under suspicion for a link to Actos heart failure, there is now the concern regarding Actos and bladder cancer. Recently, Reuters reported that the European Medicines Agency (EMA) had launched an investigation into Actos, announcing on March 18 that it was examining the benefit-risk ratio of the diabetes drug.

The spouse of a bladder cancer victim who underwent surgery for Stage 1 bladder cancer in February 2009 may be wondering if Actos was a trigger to her husband's condition. "At this time, he had been on Actos for four years," she writes, "and there was nothing on the Actos blurb about bladder cancer or male rats with tumors."

As of September 2010—the very month that the FDA came forward with its causation with regard to Actos and bladder cancer—the cancer victim was in remission and was being checked for any additional emergence of cancer every three months. The writer notes that the cancer was confined to the wall of the bladder and was not noted elsewhere.

"Bladder cancer is not a disease that is prevalent in my husband's family," the writer goes on. "Heart disease runs in my side of the family, so this was a new experience. We thought it would never happen to us. The experience was very frightening. First, the surgery took place, and everybody sat in the waiting room hoping for the best. We have already been through open-heart surgery with my husband, and we survived that ordeal. However, the cancer word is a mystery word. The prognosis is unknown."

What is known—and may be surprising to some—is that the potential for a link between Actos and bladder cancer is nothing new, according to Reuters. The risk has been under "close review" since Actos was first approved in 2000. Manufacturer Takeda Pharmaceuticals, according to Reuters, is undertaking a 10-year study to determine cancer rates in Type 2 diabetes patients taking Actos.

Three interim study reports have not shown a clear link. However, an increased number of spontaneous reports had prompted the EMA to initiate the latest review.

As for Actos and heart failure, therein lay another issue that will continue to be studied as well.