For more information or confidential assistance
se habla español

Actos Side Effects

Actos pill bottles The diabetes drug Actos, manufactured by Takeda Pharmaceuticals, is prescribed to patients diagnosed with Type 2 diabetes. The drug works to help these patients better control blood sugar spikes by enhancing the body’s sensitivity to insulin – the hormone responsible for breaking down glucose in the blood.

However, mounting evidence suggests the dangerous side effects associated with Actos may cause patients more harm than good – including potentially-fatal conditions like bladder cancer and heart failure.

While some Actos side effects are more benign in nature, thousands of patients have reported sudden, severe symptoms when taking the drug. 

Most common Actos side effects

Like most prescription of over-the-counter medications, Actos is associated with several side effects. Since Actos works to affect blood sugar levels in diabetic patients, those taking the drug run the risk of developing a condition known as hypoglycemia – a condition causing too much insulin in the blood and symptoms such as:

  • Dizziness, confusion or lightheadedness;
  • Shakiness and sweating;
  • Irritability;
  • Rapid heartbeat

Aside from these reactions, Actos may also cause patients to experience cold- and flu-like symptoms, including body aches, fever, sore throat and fatigue. Some patients have even reported symptoms including malaise or tooth pain while taking Actos. 

Bladder cancer

The FDA has recognized a possible increased risk of bladder cancer in patients taking the drug Actos. Bladder cancer is a painful, debilitating and often-deadly form of cancer affecting the lower urinary tract. Patients are advised to forgo taking the drug Actos if they have ever had bladder cancer or are currently in treatment for the condition. Patients taking Actos who experience blood in the urine, painful urination or a frequent need to urinate are advised to speak to their doctor right away.

Heart failure

Another alarming Actos side effect includes the possibility of congestive heart failure in patients taking the drug. As the name suggests, heart failure occurs when the heart muscle is unable to pump sufficient amounts of blood to the body, causing various organ systems to malfunction or “shut down.” One of the more immediate signs of heart failure is known as “edema,” and manifests by a visible build-up of fluid in the body. Edema occurs when the kidneys are not receiving the amount of oxygenated blood necessary to properly function, resulting in a decreased filtration of fluids. 

Bone fractures

Broken bones are another side effect causing patients unexpected and persistent pain and discomfort. Actos users, particularly women, appear to be more susceptible to broken and fractured bones in the hands, upper arms and feet. The data on broken bones was revealed by a study conducted in Switzerland which showed that users of Actos may be up to three times more likely to experience bone fracture after two or more years of use than those who did not take the drug. 

FDA addresses Actos side effects concerns

The Food and Drug Administration has released several warnings regarding Actos side effects, encouraging all patients to discuss the risks associated with the drug against its potential benefits. In 2007, the FDA required Takeda to place a black box warning on the product in order to better inform patients of the possible risks of heart failure when taking the medication. A black box warning is the strongest warning required by the FDA.

In 2011, the FDA further updated its Actos warnings by issuing a statement detailing the risks of bladder cancer in Actos patients. The statement reiterated that patients taking Actos longer than one year may be at an increased risk for this condition and those experiencing any of the above-mentioned urinary tract symptoms are advised to immediately contact their healthcare professional. 

Medical studies reveal risks associated with Actos

In addition to the FDA’s in-depth investigation into the safety of the drug Actos, several medical studies have been conducted to determine whether Actos is more likely to cause conditions like cancer and heart failure. In one recent study conducted at the University of Montreal, patients with Type 2 diabetes who were treated with Actos had an 83 percent higher chance of developing bladder cancer than those who did not take the drug.

Actos patients are also studied as part of a larger group of patients taking the class of drugs known as thiazolidinediones, to which Actos belongs. In one review, 2.6 million patient cases were reviewed, revealing over 3,600 new cases of bladder cancer. 

Ongoing Actos litigation

Life-threatening side effects linked to Actos have inevitably lead to the onset of litigation concerning health risks of the drug. Several thousand Actos patients have come forward over the past several years seeking redress for their injuries, including the medical expenses incurred for the treatment of these serious conditions. In general, most of the lawsuits against Takeda allege the drug maker failed to adequately warn patients of the risks of Actos and, had the patients known about the potential to develop cancer, they would have chosen an alternative course of treatment.

Most of the Actos lawsuits against Takeda were consolidated in 2011 pursuant to multidistrict litigation rules – which are designed to allow plaintiffs and defendants to more conveniently litigate the case in one court system as opposed to nationwide.