Actos Complications & Serious Adverse Events

Actos is an oral anti-diabetic medication used to treat Type II Diabetes. It works by increasing sensitivity to insulin and decreasing sugar storage in the liver. Actos has been linked to serious side effects including heart failure, bladder cancer, lactic acidosis, and bone fractures.

Quick Summary
What is Actos?

Actos (pioglitazone) is a medication used to treat Type 2 diabetes. It is a thiazolidinedione (TZD) type medication which is similar to another antidiabetic drug, Avandia. Actos works by increasing the body’s sensitivity to insulin and by decreasing sugar stored in the liver. It can only be used by Type 2 diabetics who can still manufacture their own insulin.

Though it is effective at treating Type 2 diabetes, the FDA has warned that it may cause or increase the risk for severe or life-threatening side effects such as congestive heart failure, bladder cancer, bone fractures, ketoacidosis and other serious complications. Thousands of lawsuits have been filed against manufacturers Takeda and Lilly due to injuries caused by Actos use.

Actos Side Effects

Most Actos side effects are mild to moderate and will go away with time, but some can be serious or life-threatening.

Common side effects of Actos include:

  • Sinusitis, headache or symptoms of cold/flu
  • Dizziness
  • Weight gain
  • Muscle aches
  • Arm or leg pain
  • Mouth pain or tooth problems

More severe side effects may indicate complications that can be serious or may be life-threatening such as:

  • Congestive heart failure
  • Bladder cancer
  • Macular edema
  • Lactic acidosis
  • Bone fracture
  • Liver or kidney disease

Several warnings have been issued about the increased risks of Actos, including a black box warning issued in 2007 for an increased risk of congestive heart failure and a 2011 warning about an increased risk of bladder cancer.

In 2015, Takeda settled nearly 9,000 Actos lawsuits for a total of $2.4 billion.

Actos is the brand name of pioglitazone, a member of the thiazolidinedione (TZD) class of anti-diabetic medications. It is used to treat Type 2 diabetes, previously called Non-Insulin Dependent Diabetes Mellitus (NIDDM).

Though it is effective in treating Type II diabetes, it may cause severe or life-threatening side effects. Concerns about Actos have arisen over serious adverse events such as kidney disease, bladder cancer, and bone fractures and the FDA has required that a “black box” warning be placed on Actos due to the risk of congestive heart failure. Thousands of lawsuits have been filed against manufacturers Takeda and Lilly due to injuries caused by Actos use.

What is Actos?

Insulin is required for glucose to be used by the body’s cells as energy. Actos increases the body’s sensitivity to insulin and decreases the amount of sugar that is stored in the liver. Actos can only be used on patients who are able to make their own insulin.

Actos cannot be used for Type I diabetics (insulin dependent) whose pancreas cannot manufacture insulin. It should not be used in those with a history of ketoacidosis and is contraindicated in patients with congestive heart failure.

Actos is manufactured by Japanese pharma giant, Takeda Pharmaceutical and co-marketed with Eli Lilly, one of the largest drug companies in the U.S. It is taken once daily alone or with other antidiabetic medications such as Glucophage (metformin). At its peak, Actos was the best-selling diabetes medication in the U.S. with sales over $3.85 billion.

Actos Side Effects

Actos may cause a number of side effects and though it can be taken with other antidiabetics, it may interact with certain other medications. Most Actos side effects are mild to moderate, but some can be serious or life-threatening.

Common side effects of Actos include:

  • Sinusitis, headache or symptoms of cold/flu
  • Dizziness
  • Weight gain
  • Muscle aches
  • Arm or leg pain
  • Mouth pain or tooth problems

More severe side effects may indicate serious complications and include:

  • Nausea, vomiting or stomach pain
  • Dark or bloody urine
  • Painful or frequent urination
  • Swelling or rapid weight gain
  • Shortness of breath
  • Pale or clay-colored stools
  • Pale skin
  • Yellowing skin or eyes
  • Weakness or fatigue
  • Loss of appetite
  • Extreme thirst
  • Easy bruising or bleeding

Any severe or bothersome side effects should be reported to a medical professional immediately.

Actos Complications and Serious Side Effects

Actos may cause a number of serious adverse events which can be life-threatening.

Bladder Cancer Risk

Studies show that taking Actos may increase the risk of bladder cancer, especially when taken for more than 1 year. Takeda was ordered to conduct a 10-year safety regarding bladder cancer and the FDA required that information regarding increased risk be added to prescribing information for Actos. Sales of Actos have been suspended in Europe due to bladder cancer and other risks.

Congestive Heart Failure Risk

A “black-box” warning was required by the FDA regarding a risk of developing or worsening Congestive Heart Failure. The boxed warning is a serious warning that is printed in a black box on the top of Actos prescribing information and states that patients with a history of heart failure should not take Actos.

Actos Bone Fracture Risk

Actos may increase the risk of bone fracture. This increased risk may affect more women than men and occurs mostly in the legs and arms. Risk of bone fracture may be twice as high when Actos is taken for more than three years.

Actos Kidney Disease Risk

Study results have shown that Actos may increase the risk of developing kidney disease. Kidney disease is a known risk of diabetes however, patients who took Actos were four times more likely to develop kidney disease than patients who did not take the medication.

Actos Lactic Acidosis Risk

Actos can increase the chance of developing lactic acidosis, especially when taken with metformin. Lactic Acidosis can be caused by low blood sugar levels and is increased by kidney damage, heart failure, liver damage and high alcohol intake.

Actos Drug Interactions

Though Actos may be used with other antidiabetic medications such as metformin or Glucophage, it may interact with other prescription medications including:

  • Blood thinners – Coumadin (warfarin)
  • Heart medications – Lanoxin (digoxin), calcium channel blockers, beta blockers
  • Oral Contraceptives
  • Medications affecting the liver – gemfibrozil, rifampin, cimetidine, ketoconazole

Patients should tell their healthcare providers about all of their health conditions and all of the medications that they are taking.

Actos Lawsuits

Thousands of Actos lawsuits were filed against both Takeda and Eli Lilly who manufacture and market Actos by patients and family members of those who developed bladder cancer or other serious injuries after taking Actos. In 2015, nearly 9,000 of these lawsuits were settled for a total of $2.4 billion.

Lawyers for plaintiffs argued that the drug companies were more concerned with making a profit than with patient safety.