Actos is an oral medicine prescribed to patients who suffer from Type II Diabetes, and is used to help control blood sugar levels.

A 2011 study linked the continued use of Actos to a risk of bladder cancer. From 22,512 reported side effects, 22 percent had bladder cancer. The largest concentration (approximately 43 percent) was using Actos from two to five years before having bladder cancer. The next largest concentrations (approximately 29 percent) had been using Actos from one to six months.

In 2011, the FDA announced that it would be reviewing the side effects of Actos after one study suggested that Actos patients faced a “disproportionate risk” of bladder cancer. This same study looked at half a million reports of side effects associated with diabetes medication, and found that a fifth of those involving bladder cancer occurred in patients using Actos.

The FDA issued a warning saying that Actos was linked to increased risk of bladder cancer, especially after being used for a year or more.

There have also been concerns about the safety of Actos as a possible cause of heart attacks. A whistleblower lawsuit was filed after Dr. Helen Ge stepped forward and alleged that Takeda Pharmaceuticals downplayed her concerns regarding Actos myocardial infarction cases. She also said that Takeda failed to properly report adverse events, including those for Actos-related heart attacks, to the FDA as required.

The Actos whistleblower lawsuit is of interest because the black box warning that the FDA placed on Actos in 2007 only pertained to Actos-related congestive heart failure–not Actos-related heart attacks. This revelation, if Takeda did indeed misrepresent or underreport or fail to report Actos adverse events, could potentially result in heightened Actos litigation regarding patients who suffered Actos-related heart attacks–some of whom may have submitted complaints thinking at the time that the black box warning was for heart attack risk as well as for congestive heart failure.

Other serious side effects may include:

  • Bladder Cancer
  • Heart attacks
  • Cardiovascular problems
  • Edema
  • Swelling of the feet
  • Congestive Heart Failure
  • Hepatitis
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