Actos and bladder cancer: everything old is new again

“Use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer,” according to the U.S. Food and Drug Administration’s June 15, 2011, safety announcement. In 2013, there is science suggesting that there may be better drug therapies.

Amid scientific risk-benefit debate and the continued adjudication of Actos lawsuits and settlements, a commonsensical issue is whether the drug today is worth the risk of long-term use in the first place. Medical science journals in 2013 — and, at this point, 2013 is young — address not only that issue, but also the relative increased risk of bladder cancer associated with the protracted use of Actos.

Similar conclusions abound. Everything old is new again, it seems.

Upon reviewing pharmacy records at a Birmingham, Ala., hospital, researchers concluded that Actos did not appear “preferable” to diabetes drugs of another class. (This applied also to its partner “glitazone” Avandia, the generic name of which is rosiglitazone.) Physician and microbiologist Dr. Donald H. Marks wrote about Cooper Green Mercy Hospital’s examination of the “utilization, safety and clinical use” of those type-2 diabetes medications for a January edition of The International Journal of Risk and Safety in Medicine.

The hospital switched all of the rosiglitazone prescriptions to pioglitazone, “which was estimated to result in savings of $83,000 for the first year,” according to the article’s abstract. Hospital personnel studied FDA and clinical papers on the safety and efficacy of the drugs before transitioning prescriptions.

The following observations were among the conclusions noted in the abstract: “There are no circumstances in which use of glitazone medications is preferable to other medication groups, and there are no clinical circumstances in which use of glitazone medications is absolutely necessary, as opposed to other classes of diabetic medication. There are significant contraindications, warnings and precautions to use of glitazones, which must be taken into consideration before use in every individual patient.”

The rest of this space is not devoted to the Cooper Green Mercy findings. The following perspective does not come from the hospital’s staff.

“Actos was approved July 15, 1999,” the FDA wrote in 2010, “as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.”

The FDA in September 2010 shared interim data from a study sponsored by Takeda, the maker of Actos, in which, “An increased risk of bladder cancer was observed among patients with the longest exposure to Actos, as well as in those exposed to the highest cumulative dose of Actos.”

The FDA in June 2011 announced that the drug’s warnings, precautions and medication guide would be revised to reflect what may be a seeming link between the increased bladder cancer risk and the use of Actos for more than a year.

The administration also noted in the same 2011 announcement that “France has suspended the use of pioglitazone and Germany has recommended not to start pioglitazone in new patients” based on the findings of a French epidemiological study.

The published science in 2013 continues to hit the bullseye; what’s old is new. For instance, Italian researchers analyzed 17 studies published in English through June 2012. In an article written for the February edition of The Oncologist, the authors wrote, “A modest excess risk of bladder cancer was reported in pioglitazone but not in rosiglitazone users. The [relative risks] of bladder cancer were higher for longer duration and higher cumulative dose of pioglitazone.”

Takeda should have known about the apparent association between Actos use and bladder cancer and accordingly should have informed the FDA, the medical profession, and potential Actos patients of the unreasonable risk of a serious Actos side effect — bladder cancer.

An Actos patient, or a former Actos patient, who has been diagnosed with bladder cancer may be entitled to compensation. Experienced in handling Actos lawsuits, the pharmaceutical injury attorneys at Reich & Binstock [www.reichandbinstock.com] want to help, and they offer a free consultation to anyone, in any state, who may have been victimized. Reach the law firm toll-free at 1-866-LAW-2400.