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French Medicines Agency Archives - Carey Danis & Lowe

Actos MDL 2299 Update: Periodic Review Established and Next Status Conference Scheduled

By | Actos, Pharmaceutical litigation, Uncategorized

Actos MDL 2299 Update: Periodic Review Established and Next Status Conference ScheduledAn Actos Multi-District Litigation (MDL) has been consolidated in Louisiana as of December 2011. The Actos MDL is being heard by U.S. District Judge Doherty in the U.S. District Court for the Western District of Louisiana. The MDL has been named In Re: Actos (Pioglitazone) Products Liability Litigation MDL No. 2299.

The most recent news coming from the Actos MDL regards an administrative order outlining how the MDL will be conducted. The Case Management Order, delivered on January 2, 2013, details nothing of the MDL’s purpose, but rather outlines a periodic review process. The reason for making arrangements for a periodic review is to give attorneys involved in the MDL, on both sides, the opportunity and ability to share ideas, updates, and recommendations pertaining to the how the MDL is administered.

The next Status Conference for the Actos MDL 2299 will be January 24, 2013.

Actos is a drug manufactured by Takeda Pharmaceuticals, and is prescribed to patients with type 2 diabetes. The drug was approved for use in the U.S. by the  U.S. Food and Drug Administration (FDA) in July 1999.

According to a CBS News report from June 2011, the French Medicines Agency banned sales of Actos after reviewing data gathered in a French government funded epidemiological study demonstrated a strong link between the use of Actos and the development of bladder cancer. Soon after France banned Actos, German health officials followed suit in banning new prescriptions of the drug to diabetic patients.

In America, the FDA is continues to review the safety of Actos. Upon parsing through interim data from a 10 year study being funded by Takeda Pharmaceuticals in collaboration with Kaiser Permanente Northern California, the FDA issued an Actos safety update in August 2011 about the increased risk of developing Actos linked bladder cancer after using the drug for more than one year. Though the FDA recognizes the risks of using Actos, their safety review remains ongoing.

Signs of bladder cancer include painful urination, red colored urine, blood in urine, severe pain in the pelvic region, and frequent need to urinate. If you or a loved one is currently using Actos or has used Actos in the past to treat type 2 diabetes, and you or your loved one has experienced any of these signs of bladder cancer, it is imperative to meet with a healthcare provider immediately.

Experienced pharmaceutical product liability lawyers at Carey Danis & Lowe understand the importance of holding pharmaceutical companies like Takeda Pharmaceuticals accountable for releasing drugs onto the market whose side effects have not been fully researched. It was only after Actos was on the market, and only after reports began piling up relating to Actos bladder cancer risks, did Takeda Pharmaceuticals decide to conduct a 10 year study looking into the safety of Actos.

Lawyers at Carey Danis & Lowe seek to work closely with clients in shedding light on such negligence. For a free legal consultation about your Actos case, and for more information about filing an Actos lawsuit, contact a lawyer at Carey Danis & Lowe by calling 800.721.2519.

Actos Time Line: The Fraught History Behind Takeda Pharmaceutical’s Diabetes Drug

By | Actos, Pharmaceutical litigation, Uncategorized

Actos Time Line: The Fraught History Behind Takeda Pharmaceuticals' Diabetes DrugIt has now come to light that Takeda Pharmaceuticals knew about the cancer risks associated with the ingestion of Actos, a drug they developed to treat type 2 diabetes. However, despite these known Actos bladder cancer risks, Takeda Pharmaceuticals began marketing and selling the drug upon U.S. Food and Drug Administration (FDA) approval in 1999.

 

The following time line offers a detailed look into the fraught history of Actos, from its approval to the current day legal proceedings:

  • July 1999 – The FDA approved Actos for the treatment of type 2 diabetes.
  • 2002 – The risk of heart failure while taking Actos became apparent, and as a result, the FDA required the Actos label to be updated with information about heart failure risks.
  • 2007 – The FDA mandated that the Actos label be updated to include a black-box warning about the Actos heart failure risks.
  • September 17, 2010 – After reviewing data from a 10-year epidemiological study funded by Takeda Pharmaceuticals, the FDA made an announcement that it would begin an its own investigation into the safety of Actos, and in particular the bladder cancer risk.
  • June 2011 – France announced discontinued Actos prescriptions and sales as a result of data gathered in an Actos study conducted by the French Medicines Agency from 2006 to 2009, which revealed a strong link between Actos and the development of bladder cancer.
  • June 2011 – The FDA released a warning about the risks of bladder cancer and Actos. The FDA warning mentioned that when Actos is taken for more than 12 months, there is an increased risk of developing bladder cancer. The FDA demanded the Actos label be updated with information about the bladder cancer risks.
  • July 12, 2011 – Takeda Pharmaceuticals issued an Actos recall in France.
  • July 21, 2011 – The European Medicines Agency ruled to keep Actos on the drug market, but made a recommendation that healthcare providers closely monitor patients taking Actos for any signs of bladder cancer. The EMA also recommended that a thorough screening process be established when considering prescribing Actos to new patients.
  • August 4, 2011 – The FDA (approved new warning label information about) the risk of developing bladder cancer while taking Actos.
  • September 2011 – The first Actos class action lawsuit is filed in Louisiana.
  • December 2011 – Actos lawsuits are consolidated into a Multidistrict Litigation (MDL) in Louisiana.
  • March 2012 – A former Takeda Pharmaceuticals employee, Dr. Helen Ge, sued Takeda Pharmaceuticals claiming that the pharmaceutical company deliberately withheld information about the safety of Actos from the FDA.
  • December 2012 – Defective drug lawyers at Carey Danis & Lowe are currently accepting Actos claims.

If you or a loved one has suffered from Actos bladder cancer, you may be entitled to receive compensation for your suffering and losses. Our experienced defective drug lawyers will provide you with the expert legal counsel required to hold Takeda Pharmaceuticals responsible for marketing and selling the defective drug, Actos.

For a free legal consultation regarding your Actos claim, contact a lawyer at Carey Danis & Lowe at 800.721.2519.

Carey Danis & Lowe Lawyers Examine the Link Between Actos and Bladder Cancer

By | Actos, Pharmaceutical litigation, Uncategorized

Published November 29, 2012 by PR Web

Carey Danis & Lowe Lawyers Examine the Link Between Actos and Bladder CancerSt. Louis, Missouri (PRWEB) November 29, 2012

November is American Diabetes Month and the pharmaceutical product liability lawyers at Carey Danis & Lowe are examining the relationship of Actos and bladder cancer. In recent months, the European Medicines Agency and the U.S Food and Drug Administration (FDA) have reviewed the safety of the drug and its potential to cause bladder cancer.

Based on these studies, Carey Danis & Lowe provides consultation to those who may have been harmed by Actos and may be entitled to compensation.

According to the European Medicines Agency, last fall the French Medicines Agency made the decision to discontinue prescribing medicines in France containing pioglitazone, such as Actos. The French Medicines Agency came to this resolution based off of a French epidemiological study.

This French study was undertaken by Caisse National d’Assurance Maladie, a French health insurance organization. The French epidemiological study was conducted during 2006 – 2009. From the data compiled during the French study, it became clear that there is a significant link between the use of Actos and the development of bladder cancer.

Following suit, health officials in Germany have advised German health care providers to stop writing prescriptions for Actos, specifically for new diabetes patients.

Like the European Medicines Agency, the U.S. Food and Drug Administration (FDA) is currently reviewing the safety of Actos in regards to the development of bladder cancer in patients prescribed with the diabetes drug. In this review process, the FDA is actively watching a study being conducted by Takeda Pharmaceuticals involving over 100,000 diabetes patients.

The manufacturer of Actos, Takeda Pharmaceuticals, is leading a 10-year cohort study involving patients in the Kaiser Permanente Northern California health plan. In the Takeda Pharmaceuticals and Kaiser Permanente Northern California study, a 5-year interim analysis of data was undergone, which revealed that, in patients who had taken Actos for more than one year, the researchers saw a 40% increased risk of the development of bladder cancer.

Patients who used Actos and developed bladder cancer may be entitled to compensation. Carey Danis & Lowe provides consultation to those patients who may have been harmed by Actos. Please contact our pharmaceutical lawyers to learn more and file a case.

References:

[European Medicines Agency: Update on ongoing European review of pioglitazone–containing medicines.
FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure. FDA Web site. Accessed November 14, 2012.

Diabetes Drug Actos Connected to Bladder Cancer

By | Actos, Pharmaceutical litigation, Uncategorized

Diabetes Drug Actos Connected to Bladder CancerResearch demonstrates a strong connection between the development of bladder cancer and the use of Actos, a drug prescribed to patients with diabetes. Actos is known generically as pioglitazone, and is categorized within the drug class thiazolidinedione (TZD). Actos is manufactured by Takeda Pharmaceuticals.

The U.S. Food and Drug Administration (FDA) made a decision in June 2011 to deliver a warning about the link between Actos and and increased risk of developing bladder cancer. The FDA released this warning based on information gathered from an examination of Takeda’s own ongoing study of Actos.

As a result of the FDA warning, the Actos packaging has been updated with a warning about the increased risk of bladder cancer. Furthermore, the Actos patient medication guide was also updated in a similar manner with information regarding the risks of bladder cancer.

After reviewing data collected from a French study of the drug Actos, two European countries have since banned Actos. France no longer prescribes the diabetes medicine as a result of the findings from the French  epidemiological study. The diabetes drug Actos is also banned in Germany.

The French study was conducted by the French Medicines Agency from 2006 – 2009. The Actos research study looked at the health of 1.5 million patients. During the study, the French scientists discovered a strong link between the use of Actos and the development of bladder cancer.

Another Actos study which saw data linking Actos to bladder cancer is a 10 year study of the drug undertaken by Kaiser Permanente Northern California. Starting in 2002, The Kaiser Permanente data demonstrates an 40% increased risk of developing bladder cancer from the use of Actos for more than 1 year.

Takeda Pharmaceuticals developed Actos for the purpose of intensifying the body’s ability to use insulin in order to regulate blood sugar levels in patients with diabetes. Those patients more at risk of developing bladder cancer are individuals who have been using Actos for the longest duration, and those who are prescribed high doses of the drug.

Signs of bladder cancer include the following:

  • Blood in urine
  • Red-colored uring
  • Frequent urination
  • Pain while urinating

Patients already suffering from bladder cancer, or other bladder health issues, should not take the drug Actos. Also, patients currently taking Actos should discuss stopping the use of the drug with their doctors.

If you or someone you love has suffered from bladder cancer due to use of the diabetes drug, Actos, you may be eligible to receive compensation for your suffering and losses. For more information about filing an Actos lawsuit, contact Carey Danis & Lowe. Our pharmaceutical product liability lawyers work hard to win our clients the justice they deserve.