Actos is an oral diabetes drug made by Takeda Pharmaceutical Company which was co-marketed in the United States by Ely Lilly Pharmaceuticals as Actos, Acto-plus Met, and Duetact. Takeda markets its products in more than 100 countries worldwide with its U.S. subsidiaries based in Deerfield, Illinois. Actos is Takeda’s most successful product, representing just over a quarter of Takeda’s total revenue. The treatment of diabetes was revolutionized in the 1990’s with the introduction of a class of drugs known as thiazolidinediones (“TZDs”). TZDs were first discovered by Takeda in the 1970s. Actos, which was approved by the FDA in July of 1999, is becoming the preferred TZD medication due to its greater positive effect on cardiovascular disease than other anti-diabetic drugs. Takeda continues to capitalize on Actos by developing new diabetes drugs based on the same Actos formulation, including Sonias (a type-2 diabetes treatment comprised of a fixed dose of Actos and glimepiride) and Liovel (which combines NESINA and Actos).
Actos is a diabetes medication that is prescribed for people to help them treat their symptoms associated with type 2 diabetes, and in recent years the medication has been banned in both France and Germany and the United States Food and Drug Administration has required warnings to be published on the labels of this medication that alert its users of the potential risks involving bladder cancer for those who use it for a prolonged period of time.
Studies have now confirmed that Actos greatly increases the risk of bladder cancer in certain patients. A French National Health Insurance Plan Investigation that showed significant increase in the risk for bladder cancer in patients exposed to pioglitazone compared to patients exposed to other anti-diabetic agents. According to the French review, a cumulative dose of greater than 28,000 milligrams and an exposure of longer than one year led to a significant increase in bladder cancer, particularly in men.
Pioglitazone is also an active ingredient in the medications Acto-plus Met XR, Acto-plus Met and Duetact. In June of 2011, the FDA released an Actos bladder cancer warning. The FDA’s new warning came on the heels of an interim analysis of an epidemiological study conducted by Takeda.
In 2003, the Actos label mentioned Carcinogenesis, Mutagenesis, and Impairment of Fertility. Three years later, in 2006, data from two new studies was added, as an occurrence of .44% (drug) v. .14% (control) of bladder cancer was found, meaning patients taking Actos were 3 times more likely to develop bladder cancer. Takeda is currently engaged in a ten-year observational cohort study with Kaiser Permanente Northern California, which included 193,099 Kaiser Permanente patients with diabetes. The Kaiser Permanente study showed a 30% increase in bladder cancer risk for patients taking Actos for 12-24 months and a 50% increased bladder cancer risk for patients taking Actos 2 years or longer. The review confirmed that long-term Actos users and Actos users with the highest cumulative dose of the drug did show an increased risk.
The FDA has now advised Actos users that taking the drug for longer than a year increases the user’s risk of developing bladder cancer. The longer a patient takes Actos, and/or the higher the dosage, the greater the increased risk of cancer. The FDA also acknowledged that, after a French study pointed to an increased risk of bladder cancer, Actos had been removed from the European market pending further investigation.
Patients with diabetes who were prescribed Actos allege that Takeda knew or should have known that the use of Actos in humans would cause bladder cancer. Prior to the drug’s introduction to the market in 1999, Takeda allegedly possessed studies on laboratory animals showing an increased risk of developing bladder cancers when the animals were provided the drug. Despite this evidence, the Actos lawsuit complaints charge that Takeda failed to disclose these laboratory test results to health regulators.
The complaints also charge Takeda failed to examine whether Actos was linked to bladder cancer in clinical studies on humans following its introduction to the market. Instead, the complaints allege that Takeda marketed and sold Actos without adequately warning prescribing physicians and patients that Actos could cause bladder cancer. Nor did Takeda disclose that it failed to conduct complete and proper testing and studies of Actos with regard to its link to cancer.
In June 2011, the U.S. Food and Drug Administration issued a drug safety alert warning that the use of the diabetes medication Actos for more than one year may be associated with an increased risk of bladder cancer. Subsequently, Takeda modified the label on Actos to warn patients and physicians of the increased risk of bladder cancer. However, health authorities in France suspended the use of Actos due to the risk of developing bladder cancer.
In April 2012, Health Canada, the government drug safety agency for Canada, issued a safety warning based on an ongoing study of diabetes patients using Actos. While the risk of developing bladder cancer is low, diabetes patients prescribed Actos for over a year had a double risk of bladder cancer compared to diabetes patients not taking Actos. Moreover, even the short term use of Actos may increase the risk of bladder cancer.
Other Possible Complications
The FDA has issued warnings, requesting doctors to weigh the value of the drug for diabetic control against the associated dangers to heart and bladder health. They have not, however, required Takeda Pharmaceuticals to remove the drug from the market. There have also been reports of liver and heart problems among patients taking Actos and Avandia, another TZD. A Cleveland Clinic Study found that Actos and Avandia can increase a patient’s risk of having a heart attack by up to 42 percent. The study also found that Actos and Avandia can increase the risk for liver problems, including liver inflammation, hepatitis, elevated liver enzymes (a sign of liver damage), and liver failure. Actos and Avandia can also increase the risk of bone fractures in women.
As consumers, the message from the FDA is: Patients taking Actos should consult their physician at the first sign of lower abdomen or back pain, or blood or red color urine. Actos patients are also instructed to cease taking the drug if they are receiving treatment for bladder cancer.
Your Legal Options
Our attorneys are currently evaluating cases related to Actos. If you took the drug Actos for diabetes treatment, are a non-smoker, and you were diagnosed with bladder cancer before age 65, please contact us through this simple form or our toll-free number, 800-598-0314.