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Heart Failure an Alleged Side Effect of Actos

First introduced to the market in 1999, the diabetes drug Actos was trumpeted by the manufacturer Takeda as a safe alternative to treat the disease. However, as a result of thousands of patients who suffered from Actos side effects such as congestive heart failure, the Food and Drug Administration (FDA) ordered a boxed warning to be placed on the package.

The number of people who suffered from heart failure or died after using Actos is unknown, but thousands of lawsuits seeking compensation for cancer after using Actos and other side effects are pending nationwide.

Manufacturer Takeda allegedly aware of Actos risks

Cardiomyopathy, the side effect allegedly caused by Actos, weakens the heart muscles and decreases blood circulation. This can cause arrhythmia and poor organ function. In addition, fluid retention might occur in the gastrointestinal tract, legs, arms, kidneys, liver, and lungs. The symptoms of cardiomyopathy include loss of appetite, faintness, trouble lying down, shortness of breath, coughing, fatigue, and rapid gaining of weight.

It is asserted that Takeda knew of the heart risks prior to the drug being released to the market. In a clinical trial run by the company, 5,238 patients were either given Actos or a placebo. A higher number of patients who were administered Actos suffered what was referred to as a “serious heart failure event” in comparison to those who took placebo.

Death from heart failure were substantially higher in patients taking Actos. Other trials also indicated a risk of cancer from Actos. In spite of this evidence, Takeda released the drug onto the market anyway.

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Study shows increase of heart failure in Actos users

A study published in The Journal of the American Medical Association (JAMA) said that there was an “increase (in) the risk of heart failure compared with other anti-diabetes medications.”

A joint recommendation from the American Heart Association and American College of Cardiology, released in 2012, stated that Actos use should be monitored closely and patients should discuss the risks with their doctors before agreeing to its use.

The warning was placed on the drug in 2007 in response to a growing amount of evidence that the dangers of congestive heart failure for Actos users was higher than initially thought. Takeda was accused of concealing or downplaying the risk of heart problems, leading many who were affected to hire an Actos lawyer and file a lawsuit seeking compensation from the company.

The FDA has advised any patient who has experienced side effects to report them to its adverse events program known as MedWatch.