Type 2 Diabetes Drug Actos
Actos (pioglitazone) is a member of the thiazolidinedione (TZD) group of antidiabetic drugs used to treat Type 2 diabetes. It works by increasing the body’s sensitivity for insulin and decreasing the amount of sugar that is stored in the liver.
|Manufacturer||Eli Lilly, comarketed by Takeda|
|Dosage form(s)||15mg tablet
|Normal dosage||15 to 30mg daily, may increase to maximum of 45mg daily|
Actos Side Effects
Like all medications, Actos may cause side effects. Most side effects of Actos are mild to moderate, but others may be more severe, serious, or even life-threatening.
Common side effects include:
- Weight gain
- Arm or leg pain
- Muscle aches
- Mouth pain or tooth problems
More severe side effects may include:
- Nausea, vomiting or stomach pain
- Painful or frequent urination
- Extreme thirst
- Dark or bloody urine
- Swelling or rapid weight gain
- Shortness of breath
- Yellowing skin or eyes
- Pale or clay-colored stools
- Weakness or fatigue
- Loss of appetite
- Easy bruising or bleeding
Actos may cause more serious medical complications that may be life-threatening. Actos’ manufacturer has faced thousands of lawsuits by people or loved ones of those who experienced some of these serious or life-threatening side effects.
Serious conditions which may be related to Actos use:
- Actos Bladder Cancer – Taking Actos may increase the risk of bladder cancer, particularly when Actos is taken for more than 1 year. Takeda was ordered by the FDA to conduct a 10-year safety regarding bladder cancer and independent studies have concluded a small but significant risk. The FDA has required that information regarding bladder cancer risk be added to Actos prescribing information. FDA warnings advise that the drug should not be used in patients at risk for bladder cancer. Actos is no longer sold in Europe due to bladder cancer risk and other complications but remains on the U.S. market.
- Actos Congestive Heart Failure – The FDA has required that a “black-box” warning regarding a risk of Congestive Heart Failure be added to prescribing information for Actos. The boxed warning is the most severe warning that the FDA can issue. Actos’ black box warning states that patients with a history of heart failure should not take Actos.
- Actos Bone Fracture – Actos may increase the risk of bone fractures, particularly in women. Bone fractures occur mainly in the legs and arms and recent studies have shown the risk may be twice as high as normal when Actos is taken for or than three years, particularly in women.
- Actos Kidney Disease – Studies have shown that Actos may increase the risk of kidney disease. Kidney disease is already known to be a problem in diabetic patients but when Actos is used, the risk may be four times greater than normal.
- Actos Lactic Acidosis – Actos can increase the risk of lactic acidosis, particularly when taken with another diabetes drug, metformin. Acidosis can be caused by low blood sugar and is a greater risk when the patient also has kidney damage, liver damage, heart failure or ingests high amounts of alcohol. The combination drug Actoplus Met contains both pioglitazone and metformin.
Actos Lawsuit Settlements
Takeda and Eli Lilly have faced an estimated 10,000 Actos lawsuits filed by patients and family members of those who were harmed by Actos. Lawsuits have been filed for bladder cancer, bone fracture, kidney disease and other injuries.
About 5,000 federal lawsuits were consolidated into multidistrict litigation in The U.S. District Court for the Western District of Louisiana. After losing several bellwether cases, Takeda settled about 9,000 of the Actos lawsuits in 2015 for an estimated $2.4 billion. More lawsuits may have been filed or may still be pending in state and local courts in California, Illinois, Pennsylvania, and West Virginia. Actos’ manufacturer, Takeda may also be facing antitrust lawsuits for misleading the U.S. Food and Drug Administration about its patents which improperly delayed generic medications becoming available.