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FDA’s Steps towards Establishing Actos Bladder Cancer Risks

According to the American Diabetes Association, millions of people across the nation have been diagnosed with type 2 diabetes. With such a large number of Americans inflicted with this condition, pharmaceutical companies have a very broad market in which to develop and distribute diabetes medications.

After Avandia was criticized for its increased risks of heart problems, Actos, a pioglitazone-containing drug which also has heart problem risks, became the new diabetes drug of choice. Pioglitazone-containing products have since been prescribed to 2.3 million Americans. Its wide distribution and multiple reports of a potential link to bladder cancer prompted the U.S. Food and Drug Administration (FDA) to conduct a safety review of the drug.

September 2010 FDA Safety Review

A few years after it began its 10-year epidemiological study on Actos, the FDA released a safety announcement stating that it was currently reviewing data from the on-going study. In addition to the FDA’s research, Takeda Pharmaceuticals, which developed Actos, conducted its own analysis of the drug and its connection to bladder cancer at the 5-year mark, which it provided to the FDA. Although initial findings at this safety review determined no significant connection between Actos and bladder cancer, further analyses demonstrated that, depending on the length and/or dosage of Actos-use, there was in fact an observable, though not completely conclusive, increased risk of bladder cancer.

June 2011 FDA Safety Review

After even further analyses, the FDA released another safety announcement in June 2011, warning the public that long-term use of Actos (more than one year) may increase the risk of bladder cancer. This side effect warning, which was not included on the drug’s warning label initially was added at this time. The FDA continues to evaluate data but instructs healthcare professionals to not prescribe Actos or any other pioglitazone-containing medications to patients with active bladder cancer and to only use pioglitazone-containing drugs with caution for patients with a history of bladder cancer.

When to Contact a Boston Product Liability Lawyer

If you or a loved one has been diagnosed with bladder cancer after long-term use of Actos in Massachusetts, you may be entitled to financial compensation. Contact the experienced Boston Actos lawsuit attorneys with Kiley Law Group to learn more about your legal rights and options before speaking to an insurance company or signing any forms. Our lawyers have over 30 years experience in pharmaceutical litigation and product liability and have recovered substantial verdicts and settlements on behalf of our clients.

For a free legal consultation concerning your potential Massachusetts bladder cancer lawsuit, call today at 1-888-208-1695. The call may be free, but the information, priceless.

DISCLAIMER: The Kiley Law Group is not representing any of the parties mentioned in this article at the time the article was posted. Our information source is cited within the article. If you were involved in this accident or a similar incident and have questions about your rights and legal options, call us or another reputable law firm. Do not act solely upon the information provided herein. Get a legal evaluation. We provide a free, confidential consultation to all not-at-fault persons named in this article and to their family members as well.

Diabetic Drug Actos Linked to Risk of Bladder Cancer

The U.S. Food and Drug Administration (FDA) publicly announced earlier this summer that Actos (pioglitazone), a medication aimed at treating diabetes, may place those who take the drug at a higher risk of bladder cancer. The FDA reported that this risk has been linked to patients who have taken Actos for over 1 year.

The federal agency is warning potential and current patients of this significant risk by providing additional warnings on the labels of medications containing pioglitazone, which is used in conjunction with one’s diet and exercise to manage Type 2 Diabetes.

Research conducted by the FDA over the course of 5 years showed that patients who were exposed to pioglitazone the longest and those who received higher dosages overall faced a greater risk of bladder cancer.

Studies in France and Germany have also shown that patients in those countries also faced an elevated risk of bladder cancer and have either stopped prescribing the drug or have not been recommending it to any new patients.

The FDA has further advised that pioglitazone should not be prescribed to patients who currently have bladder cancer and are in treatment. Doctors should be wary of its use in patients who have previously had this type of cancer.

Patients taking pioglitazone are advised to speak with their doctor if they have these symptoms:

  • Blood in urine
  • Immediate urge to urinate
  • Pain when urinating
  • Noticeable pain in one’s lower abdomen or back

When to Contact a Massachusetts Product Liability Lawyer

If you or someone you know has been seriously hurt in Massachusetts due to a defective product, contact the Massachusetts personal injury lawyers with Kiley Law Group to find out about your legal options before you sign any forms or talk to the insurance company.

Our dedicated team of personal injury lawyers has more than 30 years of experience and a successful track record of obtaining seven figure wins for our clients in auto accident cases, medical malpractice, child birth injuries, brain injuries, and other personal injury cases.

Call 1-888-208-1695 to receive a free legal consultation. And while the call is free, the information may be priceless.

DISCLAIMER: The Kiley Law Group is not representing any of the parties mentioned in this article at the time the article was posted. Our information source is cited within the article. If you were involved in this accident or a similar incident and have questions about your rights and legal options, call us or another reputable law firm. Do not act solely upon the information provided herein. Get a legal evaluation. We provide a free, confidential consultation to all not-at-fault persons named in this article and to their family members as well.

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