Actos Side Effects- Heart Failure, Fractures & Cancer Alleged

Actos Side Effects

Actos Side EffectsThe diabetes drug Actos is associated with such serious side effects that Consumer Reports issued this dire warning back in August 2012: “We say skip Actos as both generic and brand-name medication, unless other options have not worked.” The well-respected publication recommends drugs like Metformin instead, citing the increased risk of heart failure, bone fractures and bladder cancer as serious Actos side effects.

Meanwhile, manufacturer Takeda Pharmaceuticals has taken a wait-and-see approach, continuing to sell Actos to consumers despite clinical trial results and numerous adverse event reports filed with the FDA. As a result, thousands of Actos lawsuits are cropping up all across the country.

Side effects associated with Actos

According to clinical trials cited by RXList.com, the most commonly reported side effects of Actos include:

  • Upper respiratory problems (13.2%)
  • Headaches (9.1%)
  • Sinusitis (6.3%)
  • Myalgia (5.4%)

Other Actos side effects were minimal with the 15 MG dose, but much more apparent in 30 MG doses:

  • Edema (1.6% low dose; 12.7% high dose)
  • Flatulence (2.7% low dose; 6.3% high dose)
  • Weight Gain (2.7% low dose; 5.3% high dose)

Drugs.com lists a number of side effects that may make people want to discontinue taking Actos – from dizziness, irregular heart rate and extreme fatigue, to swelling, blurred vision and flu-like symptoms. Of particular concern are the cardiovascular incidents, which were reported in 4.8% of pioglitazone patients, compared to 1.2% of placebo patients. With angioneurotic edema, patients suffer a sore throat, shortness of breath and swelling of the lips and tongue.

Actos heart problems 

Actos now carries a black-box warning – the toughest warning given by the FDA – for its heart risks. A study published in the American Heart Association Journal Circulation found that Actos patients were at a 4% higher risk of heart attack, heart failure and death. It’s believed that the combination of Actos side effects like weight gain and edema (water retention) are the major contributors for the development of congestive heart failure in patients.

Actos and bladder cancer

Bladder cancer is the most highly publicized side effect reported by Actos users. In 2011, the FDA issued a drug safety update, stating that patients undergoing pioglitazone therapy longer than 12 months had a 40% increased risk of developing bladder cancer than people who had never been exposed to the drug. According to their statistics, there were 27.5 cases of bladder cancer per 100,000 long-term Actos users. By some estimates, the FDA’s risk assessment was rather modest. A study published in the British Medical Journal in May 2012 put the increased bladder cancer risk at 83%.

Actos bone fractures 

After analyzing 12 years of data in nearly 5,000 patients, Swiss researchers found that “glitazone” diabetes drugs Actos and Avandia doubled or even tripled the risk of bone fractures. Over 1,000 patients broke bones, with the highest rate seen in patients who refilled their prescriptions 15 or more times. Those who refilled their prescriptions just eight times doubled their risk of bone fracture. RX List says that a randomized trial found that 5.1% of Actos users fractured bones, compared to 2.5% of patients who took a placebo. Women were more prone to fractures in the hands, upper arms and feet.

Actos side effects warrant label updates

Not only has the FDA issued updates about Actos heart failure and bladder cancer risks, but the drug’s label has undergone several modifications since its debut on the market in 1999. Today the Actos label explicitly states that patients with heart failure or liver injury should not use the product. Actos is not safe for pregnant women or nursing mothers.

Furthermore, pioglitazone interacts with CYP2C8 inhibitors like gemfibrozil (which increases the drug’s concentration) and CYP2C8 inducers like rifampin (which decreases the drug’s concentration). They add that some people are allergic to components in the drug, which causes flu-like symptoms like sinusitis, sore throat, headaches and myalgia.

The Actos product label warns patients:

  • Thiazolidinediones, including Actos, causes or exacerbate congestive heart failure.
  • Dose-related edema may occur.
  • Post-marketing reports of hepatic failure, sometimes fatal – causality cannot be excluded.
  • Fractures: Increased incidence in female patients.
  • Bladder cancer: Preclinical and clinical trial data, and results from an observational study suggest an increased risk of bladder cancer in pioglitazone users.
  • Hypoglycemia: When used with insulin or an insulin secretagogue, a lower dose of the insulin or insulin secretagogue may be needed to reduce the risk of hypoglycemia.

Life-threatening side effects prompt litigation

Actos has been banned in Germany and France, following the publication of studies affirming the many dangerous side effects associated with pioglitazone. It’s still for sale in the United States, however.

Bloomberg News reports that Takeda Pharmaceutical may eventually face as many as 10,000 lawsuits over the increased bladder cancer risk alone. There are approximately 1,500 Actos lawsuits consolidated in the federal Actos MDL established in the U.S. District Court for the Western District of Louisiana. Over 1,000 more cases have been filed in state courts nationwide.

So far, two bladder cancer cases have gone to trial. A California jury awarded $6.5 million in damages to the plaintiff, but the judge later threw the verdict out due to faulty doctor testimony. A Baltimore jury ordered Takeda to pay $1.7 million for failing to warn about the risks associated with the drug. However, that verdict was also thrown out by the judge, as smoking was considered to be a major contributing factor to the plaintiff’s death. Plaintiffs plan to appeal the post-verdict decisions.

A third Actos bladder cancer trial is scheduled to take place in Las Vegas next month, with federal bellwether trials to follow in January of 2014.


  1. Consumer Reports – New Generic Version of the Diabetes Drug Actos Is One Bargain To Avoid http://www.consumerreports.org/cro/news/2012/08/new-generic-version-of-the-diabetes-drug-actos-is-one-bargain-to-avoid/index.htm

  2. RXList – Actos http://www.rxlist.com/actos-drug/side-effects-interactions.htm

  3. FDA – Update To Ongoing Safety Review Of Actos http://www.fda.gov/drugs/drugsafety/ucm259150.htm

  4. British Medical Journal - The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes http://www.bmj.com/content/344/bmj.e3645

  5. FDA – Actos Label http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021073s043s044lbl.pdf

  6. Bloomberg – Takeda May Face Up To 10,000 Lawsuits Over Actos Cancer Claims  http://www.bloomberg.com/news/2011-12-01/takeda-may-face-10-000-u-s-suits-over-actos-cancer-claims.html

  7. Japan Times – Takeda Failed To Adequately Warn Of Actos Cancer Risks  http://www.japantimes.co.jp/news/2013/09/27/business/takeda-failed-to-adequately-warn-of-actos-cancer-risks-u-s-jury-finds/#.Ulc_nNLCaSo