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European Medicines Agency Archives - Carey Danis & Lowe

European Medicines Agency’s Takes a Stand on Actos

By | Actos, Pharmaceutical litigation, Uncategorized

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European Medicines Agency's Takes a Stand on ActosThe European Medicines Agency made an effort to provide more detail on its conclusion regarding the safety of drugs containing pioglitazone, including the diabetes drug Actos. The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded in July 2011 that in patients taking medicines containing pioglitazone, such as Actos, their researchers observed an increased risk in the development of bladder cancer.

Though the European Medicines Agency recognizes the risk for patients to develop bladder cancer, they are still recommending that doctors prescribe drugs such as Actos, and other pioglitazone medications, for the treatment of type 2 diabetes.

Their recommendation does place some patients at an increased risk of developing bladder cancer, and in recognizing the threat of cancer development, the European Medicines Agency has added to their stance on pioglitazone medications that doctors prescribing such drugs must closely monitor their patients for any signs of bladder cancer.

Furthermore, the European Medicines Agency recommended that doctors should use careful discretion in determining when to prescribe drugs such as Actos.

In recognizing the link between Actos and increased risk of bladder cancer, France and Germany have made efforts to halt sales of Actos and other pioglitazone medications.

In the United States, the U.S. Food & Drug Administration is currently analyzing data being collected in a 10 year study conducted by Kaiser Permanente Northern California and Takeda Pharmaceuticals Inc., the manufacturer of Actos. After its review of data from the Kaiser Permanente and Takeda study, the FDA will make a conclusion regarding the safety of Actos and other pioglitazone medications.

Currently, the FDA recommends that Actos not be prescribed to patients who are currently suffering from bladder cancer. Signs of bladder cancer include hematuria, or blood present in urine, painful urination, back and pelvic pain, and a frequent need to urinate. If you are taking Actos and are experiencing any of these bladder cancer symptoms, contact your healthcare provider as soon as possible.

In light of the dangers associated with Actos and other pioglitazone medications, lawyers at Carey Danis & Lowe are currently accepting Actos claims.

If you or someone you love has developed bladder cancer as a result of taking Actos or pioglitazone, understand that you do not have to suffer alone. Our experienced pharmaceutical litigation lawyers work closely with clients to win them much deserved justice and compensation.

Receive a free legal consultation about an Actos lawsuit today by calling 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.