Actos is used to improve blood sugar (glucose) control in adults with type 2 diabetes. It is prescribed to patients who have trouble regulating their blood sugar with diet and exercise alone. It may be used alone or with other medicines, including insulin and metformin.
However, long-term use of Actos is linked to a number of serious health complications, including heart failure, macular edema, lactic acidosis, bone fractures, and most recently bladder cancer. It is the link to bladder cancer that is leading more than 3,000 former Actos users to file lawsuits against Takeda Pharmaceuticals, the maker of the drug.Recent activity by the United States Food & Drug Administration (FDA), as well as its European counter-part, the European Medicines Agency (EMA), has both doctors and users of the Type 2 Diabetes drug Actos (Pioglitazone) severely concerned.
Actos linked to Severe Health Complications
Studies show that extended use of the diabetes drug has been linked to as much as an 83 percent increased risk of developing bladder cancer, depending on how long the diabetes drug was used.
Bladder Cancer Symptoms:
You should contact your doctor immediately if you experience any of the following symptoms that may indicate bladder cancer.
- Bloody urine
- Pain when urinating
- Increased urge to urinate
- Unusual back pain
Why People Sue Because of Actos
Former users of Actos are filing lawsuits because many of them say they developed bladder cancer or suffered from heart problems after taking the drug for their type 2 diabetes. At the heart of the claims is that the drugmaker did not warn the public — or the U.S. Food and Drug Administration (FDA) — about the risks of Actos.
Takeda, which is the largest drug manufacturer in Japan, acknowledged in 2011 that it is a defendant in 54 Actos-related civil lawsuits related to bladder cancer. That total is now over 3,000.
Takeda is not the only defendant in every case. It is joined by U.S. drugmaker Eli Lilly, which marketed Actos for Takeda from 1999 to 2006.
FDA Warning Information: Bladder Cancer
In August 2011, the U.S. Food and Drug Administration (FDA) issued updated warning information concerning Actos and the increased risk of bladder cancer associated with the medication. The warning states that it should not be used in patients with active bladder cancer or in those with a history of the condition. Results of a 10-year study suggest that taking Actos for periods longer than 12 months may increase the relative risk of developing bladder cancer in any given year by as much as 40 percent. A study published in the May 2012 issue of the British Medical Journal puts the increased risk at 83 percent.
In June 2011, health officials in France and Germany suspended its use based on the studies showing an increased risk of bladder cancer. In August 2011, the FDA posted a safety warning concerning the increased risk of developing bladder cancer. The FDA’s warning as well as its suspended use in Germany, France and then India have prompted an increase in Actos lawsuit activity. Most lawsuits allege that Takeda, the drug’s manufacturer, knew of its link to bladder cancer but did not take sufficient actions to warn users of the risk.
Congestive Heart Failure
Actos carries a black-box warning because it can exacerbate or cause congestive heart failure. Side effects such as weight gain and water retention can place stress on the heart and respiratory system, which in very severe cases can lead to congestive heart failure. You should let your doctor know if you have a history of heart or respiratory problems.
Lactic Acidosis and Bone Fracture
Actos also carries a warning for the risk of developing lactic acidosis. Lactic acidosis is a potentially fatal condition with symptoms of stomach discomfort, decreased appetite, diarrhea, shallow breathing, muscle pain or cramping, and sleepiness.
Women who take Actos are susceptible to developing bone fractures, especially in the hands, feet, ankles and lower legs.
Interactions with Other Drugs
Some prescription medications are known to interact with Actos and may increase the risk of side effects. You should discuss any medications, supplements or vitamins that you are currently taking with your doctor. Also inform your health care provider if you smoke, drink or use illegal drugs.
The following medications may interact with Actos:
- Birth control pills
Types of Medications:
- Other diabetes medicines, including insulin
- Aspirin and aspirin-like drugs
- Anabolic steroids
- Weight loss medicines
- NSAIDs, such as ibuprofen or naproxen
- Thyroid medicines
- Some herbal dietary supplements
Certain Conditions May Be Negatively Affected by the Use of Actos:
You should always inform your doctor of any medical conditions, especially the following.
- Any diabetes issues such as macular edema or a history of diabetic ketoacidosis
- Heart problems or severe heart failure
- Type 1 diabetes
- Liver disease
- Fragile bones
- Active bladder cancer or a history of bladder cancer
- Pregnancy or plans to become pregnant