Actos Lawsuits

The FDA has recently linked Actos (generic: pioglitazone), a popular medication used to control blood sugar levels for Type 2 diabetes, to increased risks of bladder cancer in patients who had taken the medication for at least one year and at a high dose. Pioglitazone is also found in Duetact, Actoplus Met, and Actoplus Met XR.

What You Can Do & How We Can Help

The Schmidt Firm, LLP is currently accepting Actos induced injury cases in all 50 states. If you or somebody you know has been injured by Actos, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Dangerous Drug Litigation Group or call toll free 24 hours a day at (866) 920-0753.

Actos: An Overview

June 15, 2011 — In a safety announcement, the Federal Drug Administration released information that patients using Actos were at an increased risk of bladder cancer. As a result, the FDA asked Actos and other medications containing the ingredient of pioglitazone to update the Warning and Precautions section of their drug labels.

This announcement came after an FDA review of data from a five-year analysis found that patients taking Actos for at least one year and at a high dose had a 40% higher risk of developing bladder cancer. Consequently, the FDA recommends that doctors do not proscribe Actos to patients who currently have bladder cancer or have had it in the past.

Actos is a popular drug prescribed to people with Type 2 diabetes to lower high levels of blood sugar. It was approved by the FDA in July of 1999 and is manufactured by Takeda Pharmaceuticals. Actos belongs to a class of drugs called thiazolidinedione (TZD), which has only two other members. Avandia, (rosiglitazone) was pulled from general American markets in May 2011 after the FDA linked it to an increased risk of heart attack. The second member was Rezulin (troglitazone), which was pulled from the market March 2000, after it was linked to severe liver damage resulting in death or transplant.

Due to the severity of the symptoms associated with Actos, patients may want to contact a Actos lawyer at The Schmidt Firm, LLP for a free case evaluation to discuss the potential for a Actos lawsuit.

Actos Side Effects

The following side effects may be due to bladder cancer:

Blood in the urine
Red coloring in the urine
Urinary urgency
Pain during urination
Pain in back or lower abdomen

FDA Warning and Study

After completing a study of more than 193,000 people on the diabetes drug, the FDA found that Actos users who had used the drug at a high dosage and for the longest amount of time were most at risk of developing bladder cancer. Patients who used Actos at regular doses and only for a limited period did not have an increased risk of bladder cancer.

The FDA explained: “The risk of bladder cancer increased with increasing dose and duration of pioglitazone use. Compared to never being exposed to pioglitazone, a duration of pioglitazone therapy longer than 12 months was associated with a 40% increase in risk (of bladder cancer).”

Because of this information, the FDA is adding the risk of bladder cancer to the Warning and Precautions portion of the drug’s label.

Additionally, The FDA recommends that doctors should:

Not use pioglitazone in patients with active bladder cancer.
Use pioglitazone with caution in patients with a prior history of bladder cancer. The benefits of blood sugar control with pioglitazone should be weighed against the unknown risks for cancer recurrence.

Other Medications Containing Pioglitazone

These following medications, all containing Pioglitazone, will feature the FDA new safety warning on the increased risk of bladder cancer:

Actoplus Met (pioglitazone and metformin)
Actoplus Met XR (pioglitazone and metformin)
Duetact (pioglitazone and glimepiride)

Ban of Actos in France and Germany

Five days before the FDA warned of Actos and the possible risk of bladder cancer, Germany and France pulled Actos from their markets for similar concerns. France suspended the use of pioglitazone completely and Germany recommended doctors not to start pioglitazone therapy in new patients.

This ban resulted after results from a French study found similar results to the study conducted by the FDA.

France conducted a study that followed 1.5 million people with diabetes who were followed for up to 4 years. The study’s statistics showed a significant increase in the risk for bladder cancer in patients, especially males, exposed to pioglitazone compared to patients exposed to other anti-diabetic drugs.

Avandia

The FDA pulled Avandia from general markets on May 18, 2011 after data suggested Avandia patients were at a significant elevated risk of heart failure, including stroke or heart attack. Restrictions required doctors and patients to enroll in a special program in order to receive these drugs. Virtually, Avandia was discontinued, only to be used in rare cases. The drug was manufactured by GlaxoSmithKline.

This final restriction came after smaller constraints had been placed on Avandia in the past.

On September 23, 2010, the FDA notified doctors and patients that it was going to significantly restrict the use of Avandia (rosiglitazone) to patients with Type 2 diabetes who could not use any other diabetes medication. At the time, the risks were added to the Avandia label.

Rezulin

Rezulin (troglitazone) was pulled from U.S. Markets in 2000. On March 21, 2000, the FDA announced that Rezulin’s manufacture, Parke-Davis/Warner-Lambert had agreed to discontinue the drug.

Rezulin was proven to be toxic to the liver, which could lead to death or the need for a liver transplant.

At the time, Dr. Janet Woodcock, director of FDA’s Center for Drug Evaluation and Research said: “Use of Rezulin now poses an unacceptable risk to patients.”

Type 2 Diabetes

Type 2 diabetes is the most common form of diabetes. It is characterized by high levels of sugar in the blood. Because body cells and organs need to use sugar to properly function, a material called insulin moves sugar out of the blood and into the cells where it is stored for later use.

In people who have Type 2 diabetes, insulin does not properly complete this function. Virtually, their body’s insulin cannot transfer sugar from the blood and into cells, where it is needed. As a result, they develop high blood sugar levels.

Symptoms of Type 2 diabetes include:

Bladder, kidney, or skin infections
Fatigue
Weight loss
Increased hunger
Increased thirst
Increased urination
Blurred vision
Erectile dysfunction
Pain or numbness in feet or hands

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