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Actos® Litigation


Actos® (pioglitazone) is a prescription medication used to treat type II diabetes mellitus (“DM”).  It is manufactured by Takeda Pharmaceuticals North America, a wholly owned subsidiary of Takeda Pharmaceuticals Company Limited. Takeda is based in Japan, but has Research and Development facilities in the U.S., U.K., Japan, and Singapore.

Actos® was approved by the FDA in 1999.  Actos® is sold as a single ingredient product under the brand name Actos®, and it is also sold in combination with metformin (Actoplus Met, Actoplus Met XR) and in combination with glimepiride (Duetact).  Studies done on Actos® before it was put on the market demonstrated that bladder tumors were observed in the urinary bladder of male rats in a two-year carcinogenicity study. In two 3-year trials in which Actos® was compared to placebo or glyburide, there were 16/3656 (0.44%) reports of bladder cancer in patients taking Actos compared to 5/3679 (0.14%) in patients not taking Actos®. After excluding patients in whom exposure to the study drug was less than one year at the time of diagnosis of bladder cancer, there were six (0.16%) cases on Actos® and two (0.05%) cases on placebo. It was concluded that there were too few events of bladder cancer to establish causality.

However, to address the long-term risk of bladder cancer associated with Actos®, Takeda began conducting a ten-year observational cohort study in patients with diabetes who are members of Kaiser Permanente Northern California health plan. Patients selected to be in the study had DM and were ≥ 40. Patients with bladder cancer or a history of bladder cancer were excluded.  The cohort included 193,099 diabetics.  The primary outcome of the study is an incident of a new diagnosis of bladder cancer and the primary exposure of interest is Actos®.

A planned 5-year interim analysis was performed with data collected from January 1, 1997-April 30, 2008. This data revealed that after adjusting for age, sex, use of tobacco, use of other diabetes meds, and other risk factors, there was no significant increase in the risk for bladder cancer in patients ever exposed to Actos® compared to patients never exposed to Actos®.  However, the risk of bladder cancer increased with increasing dose and duration.  Those individuals on Actos® for more than one year, when compared to the population never exposed to Actors, had a 40% increased risk.

In September, 2010, the FDA reviewed this data and concluded that duration of Actos use for longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to never use. The FDA also discovered that a retrospective cohort study in France using the French National Health Insurance Plan also demonstrated a statistically significant increase in the risk for bladder cancer in males exposed to Actos for more than a year.  The French cohort included 1.5 million patients with diabetes that were followed for 4 years (2006-2009). Based on this study, France chose to suspend use of Actos (while awaiting the outcome of an ongoing European review of the risk/benefit profile) and Germany recommended not starting Actos in new patients. Of note, the European Committee for Medicinal Products for Human use of the European Medicines Agency (EMA) concluded in 2005, 2007, 2009 and 2010 that “there was no clear association of an increased risk of bladder cancer that could be confirmed.”

In March, 2011, the American Diabetes Association published Assessing the Association of Pioglitazone Use and Bladder Cancer Through Drug Adverse Event Reporting, Piccini, et al. This study looked at adverse events reports made to the FDA between 2004 and 2009.  The conclusion of that study was this “Conclusions: In agreement with preclinical and clinical studies, AERS analysis is consistent with an association between pioglitazone and bladder cancer. This issue needs constant epidemiologic surveillance and urgent definition by more specific studies.”

Based on the U.S. and French studies, the FDA issued a safety alert to the public on June 15, 2011. The FDA announced that it would continue to evaluate the data from the ongoing ten-year epi study, and it would conduct a comprehensive review of the French study. In the meantime, the FDA recommended that 1) Actos® not be taken by individuals with bladder cancer; 2) Actos® should be used with caution in patients with a history of bladder cancer; and 3) Actos® should not be stopped without a doctor’s advice, since the benefit of glycemic control needs to be weighed against the risk of cancer in each individual.  The FDA is also requiring a new safety label that will indicate that “the use of Actos for more than one year may increase a person’s chance of bladder cancer.”

The results show a greater risk of bladder cancer in patients who use high doses of the drug over a long period of time. According to the FDA, people with bladder cancer should not be treated with Actos® in light of the study.

Bladder Cancer Symptoms
Signs and symptoms of bladder cancer include:

  • Blood in the urine (hematuria)
  • Pain during urination
  • Frequent urge to urine, releasing small amounts each time
  • Urinary tract infections

Signs and symptoms of advanced bladder cancer include:

  • Lower back pain
  • Swelling of the legs
  • A mass or growth in the pelvis
  • Weight loss
  • Pain near the rectum or pelvis

Bladder cancer occurs when there is a quick and uncontrolled amount of abnormal cells growing in the bladder. In some cases, the cancer can spread to lymph nodes and other organs in the pelvis and body. When a person is diagnosed with bladder cancer, his/her doctor will conduct tests to determine the stage of the cancer. Tests can include:

  • Blood tests
  • Urine tests
  • Biopsies
  • X-rays
  • CT scans

If you are taking Actos®  and experience any of the symptoms of bladder cancer, you should visit your doctor immediately. The more advanced bladder cancer gets, the survival rate for the patient decreases.

Currently all of the Actos® cases are pending in the multidistrict litigation (“MDL”) captioned: IN RE: Actos (Pioglitazone) Products Liability Litigation, MDL 2299, United States District Court for the Western District of Louisiana, with the Honorable Rebecca Doherty presiding. For more information on the Actos® MDL, please click here.

Climaco, Wilcox, Peca, Tarantino & Garofoli, Co., LPA continues to offer free lawsuit consultations to individuals who may have experienced problems related to Actos®. Free case evaluations are available by calling 1-800-621-1062 or by filling out the form on this page.