Actos

Just like a similar drug marketed as Avandia has come under serious scrutiny by the FDA, Actos has recently alarmed consumer advocates and health experts. A recent FDA study found that patients who had taken the highest cumulative doses (longest duration and/or highest dose) of Actos had the most increased risk of developing bladder cancer.

In September 2010, the U.S. FDA began reviewing a suspected link between Actos and an increased rate of bladder cancer, based on a review of an on-going 10-year epidemiological study. Additionally, there is a significant increase in risk of heart-related side effects and cardiovascular risks associated with the drug. 

Actos and Bladder Cancer

The French National Health Insurance Plan conducted an investigation that showed that after adjusting for age, sex, and use of other anti-diabetic medications, there was a significant increase in the risk for bladder cancer in patients exposed to pioglitazone compared to patients exposed to other anti-diabetic agents.

According to the French review, a cumulative dose of greater than 28,000 milligrams and an exposure of longer than one year led to a significant increase in bladder cancer, particularly in men.

In June 2011, the French Medicines Agency suspended use of Actos use while the European Union’s European Medicines Agency (EMA) completed a risk/benefit analysis of the drug. In late July, the EMA confirmed an increased risk of bladder cancer, but determined that the benefit of Actos outweighed the risk for some patients and mandated a three- to six-month review of each individual patient. The EMA further concluded that bladder cancer could be lessened by patient selection and exclusion.

Other Actos Side Effect Risks

Additionally, a Cleveland Clinic study expressed concerns over Actos heart attack risks and cardiovascular deaths. In that analysis of 42 studies involving Avandia and Actos, it was found that these drugs increase the risk of heart attack by more than 40%, compared to the risk for those taking alternative diabetes drugs or a placebo.

Clinical evidence shows that Actos increases the risk of female patients’ bones fracturing, particularly fractures of the distal upper and lower limbs. Patients with an increased risk of bone fracture should weigh this side effect risk with potential benefits when considering treatment with Actos.

Post-marketing studies have also shown that patients taking Actos are at an increased risk of suffering from related Actos hepatitis, liver failure, inflammation of the liver, and elevated liver enzymes. Patients using Actos are urged to have their liver enzymes checked periodically.

More Details on Actos

The diabetes medication Actos (generic name pioglitazone) is taken orally.  It is manufactured by Takeda Pharmaceutical Company and is co-marketed in the United States by Eli Lilly Pharmaceuticals. Actos and related drugs are used to control type-2 diabetes in patients whose condition is not adequately controlled by diet and exercise alone.

More details on Actos

Actos belongs to a class of drugs called Thiazolidinedione drugs, which help to treat Type-2 diabetes by lowering blood glucose levels and increasing the body’s sensitivity to insulin. This drug may be prescribed alone (as Actos) or in combination with other active ingredients such as metformin (sold as Actoplus met) or glimepiride (sold as duetact).  Type-2 diabetes, which affects approximately 18 to 20 million Americans, is characterized by high blood glucose levels caused by the body’s inability to properly use insulin.

If you or a member of your family has suffered a serious injury caused by a related Actos side effect, you may be able to seek compensation for your losses and suffering. Please feel free to contact the law offices of Langdon & Emison for a free evaluation of your case.