Actos Side Effects Lawsuit - Piaglitazone Bladder Cancer Lawyer
What is Actos?
Pioglitazone is used with a diet and exercise program and sometimes with other medications, to treat type 2 diabetes (condition in which the body does not use insulin normally and therefore cannot control the amount of sugar in the blood). Pioglitazone is in a class of medications called thiazolidinediones. It works by increasing the body's sensitivity to insulin, a natural substance that helps control blood sugar levels. Pioglitazone is not used to treat type 1 diabetes (condition in which the body does not produce insulin and, therefore, cannot control the amount of sugar in the blood) or diabetic ketoacidosis (a serious condition that may develop if high blood sugar is not treated).
Diabetes Drug Actos Bladder Cancer Risks
The FDA has issued a new warning of increased bladder cancer risk associated with use of the diabetes drug Actos (pioglitazone).
The warning comes after a review of data from a five-year interim analysis of an ongoing study of Actos by the manufacturer, Takeda Pharmaceuticals.
The results show that although there was no increased risk of bladder cancer among Actos users overall, there was an increased risk of bladder cancer among those who had used the drug the longest. There was also a greater risk of bladder cancer among Actos users who had been exposed to the highest cumulative dose of the drug.
Officials say information about this risk will be added to the label of the drug as well as the patient medication guide.
FDA officials say in light of this new information, Actos should not be prescribed to people with bladder cancer or people with a history of bladder cancer.
In addition to Actos (Piaglitazone) Actoplus Met, Actoplus Met XR and Duetact is being investigated by our firm for potential Bladder Cancer lawsuits. Actoplus is a diabetes medication which contains Metformin and Piaglitazone and Duetact is a diabetes medication that contains Glimepiride and Pioglitazone.
Actos Timeline of Events
July 15 1999: Diabetes drug Actos, manufactured by Takeda Pharmaceutical , receives FDA approval and is released onto the market without ever having performed any studies in humans. The only studies ever conducted were conducted with rats.
May 2001: The first Actos study on humans begins. The study is titled PROactive Study (PROspective pioglitAzone Clinical Trial In macroVascular Events).
October 8, 2005: Results of the PROactive Study were published. While the study was established to assess cardiovascular events, it actually revealed a higher percentage of bladder cancer in patients taking Actos when compared with patients taking other type 2 diabetes medications.
2006-2009: A government-funded study collects data from diabetic patients taking Actos in France.
September 17, 2010: The FDA issues a Safety Announcement stating that it was reviewing data from an ongoing, ten-year study conducted by Kaiser Permanente to evaluate the risk associated with Actos and bladder cancer. The five-year interim review of the study revealed an increased risk of bladder cancer with increased dosages and longer duration use. Robert Spanheimer, ice President of Medical and Scientific Affairs for Takeda, denies the increased risk of developing bladder cancer associated with Actos.
June 2010: A former Takeda medical reviewer, Helen Ge, files a Whistleblower lawsuit, alleging Takeda downplayed data that revealed a link between Actos and bladder cancer.
2010: Takeda’s global sales from Actos are approximately $4.6 billion, with an estimated 2.3 million prescriptions filled in the United States.
June 10, 2011: The French Medicines Agency removes Actos from the market in France and Germany after analyzing the data collected from 2006-2009.
June 2011: European Medicines Agency (EMA), Europe’s equivalent of the FDA, temporarily suspends the sale of Actos. When Actos is put back onto the market, the EMA warns prescribers to establish a follow up plan for new patients on the drug after three to six months.
June 15, 2011: FDA issues a Safety Warning that the use of Actos for more than one year is associated with an increased risk of developing bladder cancer, prompting a label change.
August 4, 2011: The FDA approves the added language on Actos labels warning of the increased risk of bladder cancer. The updated label also recommends that healthcare providers should not use pioglitazone in patients with active bladder cancer and should use pioglitazone with caution in patients with a prior history of bladder cancer.
May 31, 2012: British Medical Journal publishes a study revealing Actos usage for a period of two years doubles the risk of bladder cancer.
July 3, 2012: The Canadian Medical Association Journal (CMAJ) publishes a study reporting Actos users have a 22% increased risk of developing bladder cancer.
September 30, 2012: Third quarter sales for Actos decreased 46.2% when compared to the third quarter sales for 2011, according to Takeda’s quarterly report.
What Do I Do If I Have Taken Actos And I Have Experienced Severe Side Effects Such As Actos Bladder Cancer?
If you have taken Actos, Actoplus or Duetact and experienced serious Actos side effects such as Actos Bladder Cancer call our Actos lawyer today to find out about an Actos lawsuit. With offices in Washington D.C. and throughout Florida we are ready to help Actos side effects victims nationwide. Let our Actos Attorneys evaluate your case for free today. Fill out our online case evaluation form on this page or call us toll free at: 1.800.856.6405 for your free, confidential case evaluation.
Ennis & Ennis, P.A. is currently handling cases for the following Actos Side Effects:
If you have experienced Actos side effects you may be entitled to compensation. Contact the Actos lawyers of Ennis & Ennis, P.A. today for information regarding your potential Actos lawsuit or for information about a possible Actos Bladder Cancer class action lawsuit. Fill out our free case evaluation form and our on-staff nurse or one of our Attorneys will contact you regarding your potential Actos case.
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