Actos Congestive Heart Failure – Black Box Warning

Diabetes drug, Actos has been linked to an increased risk of congestive heart failure and other serious side effects. In 2007, the FDA issued a black box warning regarding the risk of heart failure in users of Actos, pioglitazone and other diabetes medications.

Quick Summary
Actos Congestive Heart Failure

Actos (pioglitazone) is a thiazolidine-type antidiabetic medication used to treat Type 2 Diabetes. Though it has been effective for many people, some Actos users have developed severe side effects including heart failure, but also serious conditions such as bladder cancer, lactic acidosis and bone fractures.

In 2007, the FDA issued a black box warning regarding an increased risk of congestive heart failure in users of Actos and similar diabetes medications.

Congestive heart failure may occur or be worsened in Actos users due to fluid retention which may cause symptoms including:

  • Shortness of breath
  • Coughing or wheezing
  • Swelling in extremities or abdomen
  • Fatigue or mental confusion
  • Rapid/irregular heartbeat
  • Nausea or lack of appetite

A person with congestive heart failure may also have an increased risk of serious cardiac events such as heart attack.

Actos Black Box Warning

Based on results from a 2007 study published in the British Medical Journal (BMJ), the U.S. Food and Drug Administration required a boxed warning statement be added to prescribing information for Actos and a similar diabetes drug, Avandia.

The black box warning highlighted a connection between congestive heart failure and use of Actos and warns medical professionals against using the medication in patients with preexisting CHF.

Actos Congestive Heart Failure

The antidiabetic drug, Actos (pioglitazone) has been shown to increase the risk of congestive heart failure. In 2007, the U.S. Food and Drug Administration (FDA) issued a black-box warning regarding heart failure in patients who take Actos and similar medications used to treat diabetes. A black box or boxed statement warning is the most severe type of safety alert that can be issued by the FDA.

Actos’ 2007 black box warning came after a study published in British Medical Journal concluded that thiazolidine-type antidiabetics like Actos may nearly double the risk of congestive heart failure.  Based on this study and other information, the American Heart Association recommended that patients with a history of heart failure should not use Actos. The FDA subsequently issued a black-box warning about Actos and heart failure.

Actos and Congestive Heart Failure Risk

Congestive heart failure occurs when the heart muscle has become weakened and is no longer able to pump blood efficiently to vital organs.  It is called “congestive” heart failure because fluid buildup, known as pulmonary edema, which may “congest” the lungs. In addition, fluid buildup in the body may result in edema in the extremities or abdomen and may increase the chance of having a heart attack.

Use of Actos may cause fluid retention and increase the risk of developing congestive heart failure.  In addition, patients who already have a history of congestive heart failure are at increased risk of worsening the condition.  In severe cases or over time, congestive heart failure may lead to myocardial infarction or heart attack.

In addition to requiring the boxed statement on Actos, the FDA required the warning to be added to a similar drug, Avandia, which works in the same way and is a member of the thiazolidine class of anti-diabetics.

Despite the risks of CHF, in 2008 Actos was one of the top 10 medications sold in the U.S. and continued to be a blockbuster for its manufacturer Takeda.  In addition to CHF, Actos has also been shown to increase the chance of bone fractures, bladder cancer, lactic acidosis and kidney failure. Several label changes have been required because of these concerns and some countries have banned the use of both Avandia and Actos.

Symptoms of Congestive Heart Failure

Heart “failure” does not necessarily mean that the heart has stopped functioning but that it does not function properly.  Symptoms of heart failure may occur when the heart is unable to adequately pump blood throughout the body. If the heart muscle becomes weakened and cannot efficiently pump blood to vital organs, the kidneys may be unable to rid the body of excess water.

Fluid retention due to heart failure may cause swelling in the extremities (edema) and the abdomen (ascites).  Fluid may also collect in the lungs (pulmonary edema) to cause lung “congestion”. As fluid builds up, it becomes even harder for the heart to pump blood and the heart is further weakened.  In severe cases or over time, congestive heart failure may increase the chance for heart attack and death.

Symptoms of congestive heart failure may include:

  • Shortness of breath (dyspnea)
  • Chronic coughing
  • Wheezing
  • Swelling in extremities (edema)
  • Swelling or fluid retention in abdomen (ascites)
  • Fatigue
  • Rapid/irregular heartbeat
  • Mental confusion
  • Nausea or lack of appetite

Actos and Heart Attack

Certain medications, including Actos, may increase the chance for fluid retention and worsen the risk of developing heart failure.  Patients who already have a history of heart failure are at greater risk when taking Actos. The American Heart Association has warned that Actos should not be taken by patients with certain cardiac conditions, including patients with heart failure.

Symptoms of myocardial infarction or heart attack include:

  • Pain in chest, arm, jaw or shoulder
  • Pressure on chest
  • Sudden dizziness or fatigue
  • Cold, clammy skin or sweating
  • Anxiety, feeling of doom
  • Palpitations or shortness of breath

Symptoms of congestive heart failure or other severe side effects of Actos should be reported to a medical professional immediately. Symptoms of heart attack should be treated as a medical emergency.

Actos Black Box Warning

A black box warning, or black label warning, is the most serious advisory that can be issued by the FDA for any medication. It is a warning to doctors and patients that the drug could have potentially fatal effects in high risk patients.  A black box warning is printed at the top of prescribing information and is outlined in a thick, black border to be clearly seen by prescribers.

The Actos black box or boxed statement warns that Actos may increase the risk of developing congestive heart failure and states that patients who have heart failure may be at higher risk.  Patients with a history of heart problems, especially heart failure, are advised to avoid the use of Actos for treating their type 2 diabetes symptoms.

Actos Congestive Heart Failure Lawsuits

Actos is manufactured by Japanese pharma giant, Takeda Pharmaceuticals and comarketed by U.S. pharma company, Eli Lilly.  The companies have faced thousands of lawsuits regarding harm caused by Actos, including congestive heart failure. Plaintiffs have claimed that the company failed to adequately warn the public regarding the risks of the medication.

Notwithstanding claims relating to this product, the drug/medical device remains approved by the U.S. FDA.