The diabetes drug Actos may lead to heart failure, even with patients who do not have a history of heart problems or cardiac irregularities.

What is Actos?

Actos (pioglitazone) is a diabetes medication that is part of the thiazolidinedione-type or “glitazones” drug class. These drugs help to restore the way the body responds to insulin. This can help lower blood sugar.

By controlling high blood sugar caused by diabetes, patients can help prevent serious health complications such as kidney damage, blindness, nervous system issues, loss of limbs, sexual function problems, heart attack, and stroke.

What Are the Side Effects of Actos?

Side effects of Actos may include sore throat, muscle pain, weight gain and tooth problems. Rarely, the drug can cause low blood sugar if combined with other diabetes medications.

The drug may also be associated with liver disease, although this is not common. Symptoms of liver disease may include dark urine, yellowing of the eyes and skin (jaundice), nausea, vomiting, and abdominal pain. It may additionally be linked to bladder cancer.

A serious allergic reaction is also rare but may occur. Symptoms of an allergic reaction to Actos may include rash, itching, swelling of the face, tongue, and throat, dizziness, and trouble breathing.

Some patients have asserted that Actos may be linked to more serious conditions however, including heart failure and bladder cancer. Bloomberg Law reports on a lawsuit in which patients and health insurers sued Actos makers Eli Lilly and Takeda Pharmaceuticals with some of these assertions. 

The patients and insurers asserted that the drug makers were well aware that Actos could inscrase a patient’s risk of developing bladder cancer, but concealed this information. According to the Actos bladder cancer class action lawsuit, the companies violated the Racketeer Influenced and Corrupt Organizations Act and committed mail and wire fraud by misrepresenting their products.

The patients state that the drug makers could have changed Actos’ label to reflect these risks, but the companies chose to not do so in order to protect its own profits.

Initially, the Actos bladder cancer class action lawsuit was revived after being thrown out by the Second and Seventh Circuit courts, which stated that the consumers and insurers did not have sufficient standing to sue. However, the Ninth Circuit revived the claims, saying that consumers and insurers had sufficiently established their argument such that it should move forward. The Ninth Circuit court was in line with the decision made by the First and Third Circuit courts.

The Ninth Circuit court worried that allowing Eli Lilly and Takeda Pharmaceuticals off scot-free would allow drug makers to “continuously hide behind prescribing physicians and pharmacy benefits,” while putting patients at risk for serious side effects.

The Actos Bladder Cancer Class Action Lawsuit is IUPAT Dist. Council 82 v. Takeda Pharm. Co., Case No. 1:18-55588, in the Ninth Circuit Court.

Can Actos Cause Heart Failure?

Although Actos is associated with minor and rare side effects, the drug may also be associated with cardiac failure.

Heart failure refers to any time the heart doesn’t function as well as it should, making the organ unable to pump blood throughout the body effectively. Symptoms of cardiac failure may include:

• Shortness of breath
• Coughing
• Wheezing
• Edema (swelling or fluid retention in the limbs)
• Ascites (swelling and/or fluid retention in the abdomen)
• Fatigue
• Irregular heartbeat
• Mental confusion
• Nausea or decreased appetite

Cardiac failure may be caused by any condition that weakens the heart, including coronary artery disease and high blood pressure. However, studies suggest that Actos may also be linked to cardiac failure.

In 2007, the British Medical Journal published a study that showed patients on Actos and other glitazones may be at a doubled risk of congestive cardiac failure. After this, the U.S. Food and Drug Administration (FDA) required their most prominent black box warning on the drug’s labeling to warn patients, doctors, and pharmacists of cardiac failure risk.

In 2016, Indian researchers published Actos research in the Journal of Pharmacology & Pharmacotherapeutics which showed that cardiac failure can even occur in patients with normal ventricle function. Although the condition is well documented in patients with underlying heart problems, the researchers presented the case of a 65 year old man with no other heart issues who developed heart failure within a year of treatment with Actos.

“To summarize, evaluate every patient on pioglitazone, particularly with multiple medications, old age, and chronic renal disease, for all possible side effects by careful monitoring and follow-up,” the researchers concluded.

Actos Warnings

Some patients claim that they were not sufficiently warned of the heart failure dangers associated with Actos. Only after experiencing the condition did some patients allegedly discover the risks.

Despite the threat of Actos complications, Takeda Pharmaceuticals allegedly failed to inform patients and the medical community of the possibility of congestive heart failure and other dangerous side effects of their drug, like Actos bladder cancer.

Several consumers have taken legal action against Actos’ manufacturer, claiming that they had a duty to warn consumers of the risks. Those individuals injured from using Actos should consult with a lawyer about their options.