What is Actos?
Actos (generic: pioglitazone) is an oral medication that helps control blood sugar levels in patients with type 2 diabetes. The drug works by decreasing the amount of glucose released by the liver. Actos is made by Takeda Pharmaceuticals, and was approved by the U.S. Food & Drug Administration (FDA) in July 1999.
What’s the Problem?
Multiple studies have linked Actos to cancer, heart failure and other serious side effects. These injuries have led thousands of people to file lawsuits seeking compensation for damages caused by the medication. In April 2015, Takeda settled about 9,000 Actos lawsuits for $2.37 billion.
Actos and Bladder Cancer
In June 2011, FDA issued a Drug Safety Communication regarding an increased risk of bladder cancer associated with Actos. The warning followed a review of data from an interim analysis of a 10-year study of Actos conducted by Takeda.
The results indicated that although there was no overall increased risk of bladder cancer among Actos users, there was an increased risk for the disease among patients who took the drug for the longest period of time. There was also an increased risk of bladder cancer among Actos users who took the highest cumulative dose of the medication.
Prior to the FDA’s warning, several European markets including France and Germany suspended or severely restricted the use of Actos, citing concerns over the drug’s link to bladder cancer.
Bladder Cancer Symptoms
- Blood or blood clots in the urine
- Pain or burning during urination
- Frequent urination
- Feeling the need to urinate many times throughout the night
- Feeling the need to urinate, but not being able to pass urine
- Lower back pain on one side of the body
Actos and Pancreatic Cancer
A July 2015 study published in JAMA Internal Medicine linked the use of Actos to a 41% increased risk for pancreatic cancer, a disease that kills over 40,000 men and women in the U.S. each year. The researchers cautioned that additional research is needed to investigate the matter, and that the study did not prove that Actos causes pancreatic cancer since inflammation is a key risk factor for the disease and chronic inflammation is common in patients with type 2 diabetes.
The study cited above also found a link between Actos use and a 13% increased risk for prostate cancer, a disease that begins in a man’s prostate, a small walnut-shaped gland that produces seminal fluid. For the study, researchers looked at data on more than 193,000 patients aged 40 and older from 1997 to 2002. The results indicated that Actos users were 13% more likely to develop prostate cancer compared to patients who did not take the drug.
“The increased prostate and pancreatic cancer risks associated with ever use of pioglitazone merit further investigation to assess whether they are causal or are due to chance, residual confounding, or reverse causality,” the researchers concluded.
Actos Side Effects
Serious side effects of Actos may include:
- Bladder cancer
- Pancreatic cancer
- Prostate cancer
- Congestive heart failure
- Myocardial infarction (heart attack)
- Liver damage
- Bone fractures
- Macular edema
- And more
In April 2015, Takeda agreed to settle about 9,000 Actos lawsuits for between $2.37 billion and $2.7 billion, depending on the number of plaintiffs who signed onto the agreement. The settlement followed 8 jury verdicts, 5 of which were won by plaintiffs (although 2 later were overturned on appeal). Many of the settled cases were part of MDL No. 2299. There are still a number of outstanding claims.
July 15, 1999 – Approved by the FDA
July 15, 1999 – Actos first approved by the FDA.
2002 – Heart Failure Risk
2002 – Actos linked to increased risk for heart failure.
August 14, 2007 – “Black box” warning required
August 14, 2007 – FDA requires “black box” warning on the labeling of Actos regarding heart failure risk.
April 2009 – Study findings on macular edema
April 2009 – Study finds that Actos more than doubles the risk for an eye disorder called macular edema that can cause vision damage and even blindness.
September 2010 – FDA reviews study
September 17, 2010 – FDA begins reviewing data from 10-year Actos study.
2011 – First lawsuits filed
2011 – First Actos bladder cancer lawsuits are filed against Takeda.
August 2011 – FDA Drug Safety Communication
August 4, 2011 – FDA Drug Safety Communication indicates that taking Actos for 1 year or more “may be associated with a 40% increased risk of bladder cancer.”
December 2011 – MDL created
December 29, 2011 – Federal Actos lawsuits are combined into a multidistrict litigation (MDL No. 2299) in the Western District of Louisiana.
March 2012 – Whistleblower lawsuit filed
March 2012 – Whistleblower lawsuit filed against Takeda by former employee who claimed the drugmaker hid information about Actos side effects.
July 2012 – Pulled off the market
July 2012 – Actos pulled off the market in France after study links the drug to an increased risk for bladder cancer.
April 2014 – $9 billion awarded
April 2014 – $9 billion awarded to a man who developed bladder cancer after taking Actos. The award was later reduced to $37 million.
April 2015 – Takeda settles
April 2015 – Takeda agrees to settle about 9,000 Actos lawsuits for $2.37 billion.
- “Actos Drug Approval Package”. U.S. Food & Drug Administration (FDA). July 15, 1999.
- “Manufacturers of Some Diabetes Drugs to Strengthen Warning on Heart Failure Risk: Companies Will Include Boxed Warning on Drug Label”. U.S. Food & Drug Administration (FDA). August 14, 2007.
- “Fracture Risk in Type 2 Diabetes: Update of a Population-Based Study”. Journal of Bone and Mineral Research. August 2008.
- “Glitazone Use Associated with Diabetic Macular Edema”. American Journal of Ophthalmology. April 2009.
- “FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure”. U.S. Food & Drug Administration (FDA). September 17, 2010.
- “FDA Drug Safety Communication: Updated drug labels for pioglitazone-containing medicines”. U.S. Food & Drug Administration (FDA). August 4, 2011.
- “IN RE: Actos (Pioglitazone) Products Liability Litigation”. United States District Court, Western District of Louisiana.
United States District Court for the Western District of Louisiana
- “Pioglitazone and risk of bladder cancer among diabetic patients in France: a population-based cohort study”. Diabetologia. March 31, 2012.
- “Bladder Cancer – Symptoms and Signs”. American Society of Clinical Oncology (ASCO). June 2015.
- “Pioglitazone Use and Risk of Bladder Cancer and Other Common Cancers in Persons With Diabetes”. JAMA Internal Medicine. July 21, 2015.