In July 2011, the U.S. Food and Drug Administration informed the public that the use of the diabetes medication Actos (pioglitazone) may be associated with an increased risk of cancer. When used for longer than one year and at high doses, Actos is linked to higher risks of bladder cancer, the FDA says.
Do I Have an Actos and Cancer Lawsuit? Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged. If you or a loved one have taken Actos and been diagnosed with bladder cancer, you should contact our lawyers immediately. You may be entitled to compensation by filing a Actos lawsuit.
$9 Billion Award in Louisiana Actos Bladder Cancer Lawsuit
April 8, 2014 – In the seventh-largest jury verdict in U.S. history, Takeda and Eli Lilly have been ordered to pay $9 billion in punitive damages for failing to warn about the risk of bladder cancer. Judge Rebecca Doherty, who also oversees more than 2,700 Actos lawsuits, penalized the companies for destroying thousands of documents on over 40 employees involved in development and sales of Actos. Click here to read more.
Actos and Cancer: An Overview
Actos (pioglitazone) is a diabetes medication that was FDA approved in July 1999. Used in combination with lifestyle changes in diet and exercise, Actos stabilized the body’s sensitivity to insulin, a naturally-occurring substance in the body that helps control blood sugar levels.
The medication is manufactured by Takeda Pharmaceuticals and approximately 2.3 million patients received prescriptions for it last year, according to the FDA.
Unfortunately, the FDA announced in a Drug Safety Communication on June 15, 2011, that five-years worth of research by the drug’s manufacturer suggests the medication is linked to higher risks of bladder cancer, especially if taken for longer than one year and at the highest doses.
The FDA’s information was released almost simultaneously as results were made public from a French study. The findings of the French study prompted France to suspend Actos and pioglitazone use, while Germany is recommending doctors do not prescribe it to any new diabetes patients.
Meanwhile, the FDA is advising doctors not to prescribe Actos to patients with active bladder cancer, and to use caution prescribing it to patients with a prior history of bladder cancer.
Due to the severity of symptoms associated with Actos induced cancer, Actos cancer patients may want contact an Actos attorney or lawyer with The Clark Firm to discuss the potential for a Actos cancer lawsuit.
Actos Cancer Side Effects
Signs and symptoms of Actos-induced bladder cancer may include:
- Blood in the urine
- Red coloring in the urine
- Increased urinary urgency or frequency
- Urinary pain
- Urine leakage
- Abdominal pain
- Bone pain or tenderness
- Weight loss
Studies on Actos and Cancer
In June 2011, the FDA reviewed information from a five-year analysis Takeda Pharmaceuticals is conducting on Actos and its potential to cause cancer. While the study is intended to be an on-going, ten-year epidemiological study, the FDA reviewed preliminary information after only the first five years. The study includes 193,099 patients with diabetes.
The five-year results showed that although there was no overall increased risk of bladder cancer associated with Actos and pioglitazone use, there was an increased risk noted among patients with the longest exposure, as well as among patients with the highest cumulative dose.
Said the FDA about the study’s findings:
“The risk of bladder cancer increases 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 . . . Based on these data, FDA calculated that duration of therapy longer than 12 months was associated with 27.5 excess cases of bladder cancer per 100,000 person-years follow-up, compared to never use of pioglitazone.”
Simultaneously, a European study from the French National Health Insurance Plan followed approximately 1.5 million diabetes patients for up to 4 years. The results found a significant increase in the risk for bladder cancer in patients exposed to pioglitazone, compared to patients exposed to other anti-diabetic agents. These results intensified depending on increased dose or exposure length.
Based upon these results, France suspended use of pioglitazone and Germany recommended not to start pioglitazone therapy in new patients.
The bladder is the balloon-shaped organ in the pelvic area that stores urine. Bladder cancer is a type of cancer that begins in the bladder, most often in the cells that line the inside of the bladder.
While easily treatable if caught early, bladder cancer is likely to recur. As a result, bladder cancer survivors continue to receive regular checkups to look for signs of recurrence years after treatment. On average, bladder cancer is estimated to occur in about 20 per 100,000 people in the United States per year.
Several factors increase the risk of developing bladder cancer. These risk factors include:
- Increasing age
- Being white
- Being a male
- Exposure to certain chemicals
- Previous cancer treatment
- Chronic bladder inflammation
- Personal or family history of cancer
If untreated, bladder cancer can spread to surrounding tissues. It can spread to the prostate, uterus, vagina, lungs, bones or liver.
FDA Recommendations Regarding Actos and Cancer
On August 4, 2011, the FDA informed the public that the Agency was approving a drug label update on pioglitazone-containing medications to reflect the risk of bladder cancer.
The updated labels recommend health care professionals:
- Not use pioglitazone in patients with active bladder cancer.
- Use pioglitazone with caution in patients with a prior history of bladder cancer.
The updated labels recommend patients should:
- Contact their healthcare professional if they experience any sign of blood in the urine or a red color in the urine or other symptoms such as new or worsening urinary urgency or pain or urination since starting pioglitazone, as these may be due to bladder cancer.
Do I Have an Actos and Cancer Lawsuit?
Collen A. Clark is a true advocate for his clients and is passionate about helping Texans that have been injured or wronged.
Collen’s amazing success in the courtroom and well known dedication to his clients has earned him the recognition of his peers as one of The Top Trial Lawyers in Texas.”
The Clark Firm has assembled a team of trial lawyers with more than 100 years experience, participation in over 600 jury trials and $60 million in verdicts and/or settlements. Please use the form below to contact us for a free Actos cancer lawsuit review or you may also call us directly by dialing (866) 879-3040.