Pioglitazone is a medication used to treat Type 2 diabetes. The U.S. Food and Drug Administration (FDA), despite mixed study results, has issued a caution to medical professionals regarding prescribing this drug. A potential link between pioglitazone and an increased risk of bladder cancer has been found, reports Oncology/Nursing News.
Pioglitazone improves blood sugar control in adults that have Type 2 diabetes by lowering insulin resistance, where cells do not fully respond to insulin. Insulin is a hormone that controls the amount of sugar (glucose) in the blood.
Brand names for pioglitazone-containing medicines are Actos, Actoplus Met, Actoplus Met XR, Duetact, and Oseni.
In September 2010 and June 2011, the FDA announced to the public the potential risk of bladder cancer based on interim results from a 10-year epidemiologic study. At that time, the FDA changed the labels of pioglitazone-containing medicines to include warnings about the bladder cancer risk. The updated label told physicians not to prescribe this drug for patients with active bladder cancer, and to be cautious when using it in patients with a prior history of the disease.
Personal injury attorneys at Parker Waichman LLP are actively reviewing potential lawsuits on behalf of individuals who have been injured by adverse side effects of pharmaceuticals, including Actos, and other anti-diabetes medications.
Pioglitazone Study Results
Drug manufacturer Takeda Pharmaceuticals, conducted a 10-year prospective cohort study. The study included 158,918 patients who had never taken pioglitazone, and 34,181 patients who had previously taken the drug. Individuals who had never used the drug were tracked for an average of 8.9 years and those who had taken the medication were followed for 6.1 years.
There was no significant increase of risk in patients who had taken the drug when compared in the five-year interim reports of this study, to those who never had taken it before. But, the risk of bladder cancer did increase when the duration and dose of pioglitazone use increased.
The final results of the 10-year study revealed 1,075 cases of bladder cancer in patients who had never used Actos, and 186 cases in those patients who had previously used the medication. These results did not show an increased risk of bladder cancer linked to pioglitazone use. The connection between higher risk and increased dose/duration was also weaker in the 10-year report. In spite of the 10-year results being less noteworthy than the five-year interim reports, the FDA said, “the directions of the associations remained unchanged.”
An additional retrospective cohort study had 145,806 patients newly treated with antidiabetic drugs, including 10,951 treated with pioglitazone. After a follow-up of 4.7 years, study researchers found 622 new cases of bladder cancer. Of those cases, 54 contracted bladder cancer after Actos use. A larger cumulative dose and longer use significantly increased the risk, reports Oncology/Nursing News.
Actos has been approved by the FDA and available since 1999. It became the world’s best-selling diabetes drug in 2007 after the competitive drug Avandia (rosiglitazone) was associated with a higher risk of heart attack. Prior to the FDA’s approval of Actos, premarket studies revealed bladder tumors had developed in animals. This led to the ten-year study to examine long-term bladder cancer risks.
Actos Legal Problems
A lawsuit filed in July 2016 reported a plaintiff’s claims that he took Actos from 2004 to 2010 and was diagnosed with bladder cancer, which he alleges is directly connected with his use of Actos. The lawsuit claims permanent injuries, pain, suffering, and mental anguish. The plaintiff alleges that Takeda Pharmaceuticals did not warn patients or healthcare providers about the bladder cancer risk, the Louisiana Record reports.
There were over 4,500 lawsuits as of June 15, 2016, consolidated in a multidistrict litigation (MDL). An MDL is when lawsuits are centralized when there are a number of cases with common allegations. MDLs make complex litigation more efficient as similar lawsuits are brought together in one court before one judge, which helps eliminate duplicate discovery and conserves resources. In this case, plaintiffs similarly allege that Actos manufacturers failed to warn about the risk of bladder cancer.
Bladder Cancer Symptoms
The first bladder cancer symptom is frequently hematuria (bloody urine). Hematuria is normally short-lived and does not cause pain. In most cases blood is not visible and urinalysis is required for a comprehensive diagnosis. Other symptoms are frequent bladder infections and urination, back pain, lower abdominal pain, and painful urination.
Legal Information and Advice for Actos Users
If you or someone you know suffered adverse side effects involving the use of Actos or other medications, you may have valuable legal rights. The attorneys at Parker Waichman LLP offer free, no-obligation case evaluations. We urge you to contact our personal injury lawyers at 1-800-YOURLAWYER (1-800-968-7529).