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Actos Bladder Cancer and Heart Disease


Actos (pioglitazone hydrochloride) is a member of a class of drugs known as thiazolidinediones, which have been linked to bladder cancer, liver disease and cardiovascular issues. Actos side effects include increased risk of congestive heart failure (CHF), increased risk of rare but serious liver problems, an increased risk of fractures, and an increased risk for bladder cancer. A black box warning exists for Actos and heart failure, however, an Actos whistleblower lawsuit suggests a previously known but downplayed link between Actos and myocardial infarction (Actos heart attack). Actos is used to treat type 2 diabetes.

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Actos Bladder Cancer


The FDA has issued a warning that Actos may be linked to an increased risk of bladder cancer, especially in patients who use the medication for more than one year. Information about the risk of bladder cancer will be added to the Actos warning label. Preliminary results from a long-term observational study found an increased risk of bladder cancer in patients with the longest exposure to Actos and the highest cumulative dose of the drug. Patients who have bladder cancer are urged not to use Actos, while the medication should be used with caution in patients who have a prior history of bladder cancer, the FDA warns.

Meanwhile, both Germany and France have suspended sales of Actos. The Actos suspension is effective July 11, 2011. Actos (pioglitazone), along with another diabetes drug made by Takeda Pharmaceutical, Competact, came under fire in Europe after a study revealed an increased risk for bladder cancer among diabetes patients who were taking the medication. The announcement of the suspension for Actos bladder cancer concerns may affect an estimated 230,000 individuals who currently use Actos or Competact in France alone, and those who have been prescribed Actos or Competact will now need to switch to another diabetes medication.

Lawsuits have now reportedly been filed against Takeda Pharmaceuticals, alleging patients who took Actos developed bladder cancer. According to The Washington Post (08/05/11), the first of potentially thousands of lawsuits were filed in early August, alleging use of Actos was linked to the development of bladder cancer.

Actos Heart Attack Link

Concerns about the safety of Actos have become the focus of an Actos whistleblower lawsuit. A former Takeda Pharmaceuticals consultant, Dr. Helen Ge, has stepped forward and alleged that Takeda downplayed her concerns regarding Actos myocardial infarction cases and that Takeda failed to properly report adverse events, including those for Actos heart attack, to the FDA as required.

The Actos whistleblower lawsuit is of interest because the black box warning that was placed on both Actos and Avandia in 2007 only pertained to Actos congestive heart failure--not Actos heart attack. This revelation, if Takeda did indeed misrepresent or underreport or fail to report Actos adverse events, could potentially result in heightened Actos litigation regarding patients who suffered Actos heart attack--some of whom may have submitted complaints thinking at the time that the black box warning was for heart attack risk as well as for congential heart failure.

Actos Rhabdomyolysis & Actos Kidney Failure

The US Food and Drug Administration (FDA) has announced a potential safety issue with Actos (pioglitazone HCL) being linked to rhabdomyolysis. A potential safety issue means that the FDA has not established that there is a causal link between the two but that the drug is associated with the risk. FDA is evaluating the issue to determine if there is a need for regulatory action regarding Actos and rhabdomyolysis.

Heart FailureRhabdomyolysis is a rare condition in which the muscle fibers deteriorate, resulting of the release of myoglobin into the blood flow. Rhabdomyolysis is characterized by muscle aches, pains and weakness. Rhabdomyolysis can result in kidney failure. The symptoms of rhabdomyolysis can include muscle weakness, fever, fatigue, pain or contracture, nausea, vomiting and dark colored urine. Because these symptoms can be easily confused with other ailments or conditions, it is important to report an onset of any such symptoms to your doctor.

Actos Heart Failure

Actos vs Avandia. A recent study funded by the Ontario Ministry of Health and Long Term Care and published on August 19, 2009, in the British Medical Journal has found that patients taking Actos have a lesser risk of developing heart failure or dying than patients taking rival drug Avandia. Researchers studied prescription data for nearly 40,000 patients age 66 and older who took Avandia or Actos between April 2002 and March 2008. However, despite the lessened risk, experts said patients with heart failure should avoid taking Actos. Actos has been linked to a risk of congestive heart failure.

While the study found Actos to present a lower potential risk of heart failure than Avandia, the study found no significant difference between Actos and Avandia when it came to a risk of heart attacks.

Actos vs Glyburide. Meanwhile, a 24-week post-marketing safety study was performed to compare Actos to glyburide (a drug that is also used to treat type 2 diabetes and is in a class called sulfonylureas) in uncontrolled diabetic patients. Over the course of the study, overnight hospitalization for congestive heart failure was reported in 9.9% of patients on Actos compared to 4.7% of patients on glyburide.

A 2005 study found that patients in the high risk group who were taking Actos had an increased risk of weight gain, edema, non-serious hypoglycemia and heart failure. The study, called the PROactive Study, was published in 2005 in the medical journal The Lancet.

According to a "Dear Colleague" letter, found online at fda.gov and sent by Takea and Eli Lilly and Company, Actos has been found to cause fluid retention, which can lead to heart failure.

Actos FDA Warning

In 2002, the package label included the following warning regarding the risk of Actos side effects: "In insulin combination studies, a small number of patients with a history of previously existing cardiac disease developed congestive heart failure when treated with ACTOS in combination with insulin." In July, 2004, the label was changed to add "Carcinogenesis, Mutagenesis, Impairment of Fertility" to the precautions.

Actos is used to treat type 2 diabetes, sometimes in conjunction with insulin. It was initially approved for use in 1999.

Actos Lawsuit FAQ

faqsarticle What is Actos?
Actos, known generically as pioglitazone hydrochloride, is in a class of drugs known as thiazolidinediones. It is used to treat type 2 diabetes and was initially approved by the FDA in 1999.

What are Actos side effects?
Actos has been linked to side effects including rhabdomyolysis, heart failure, weight gain, fractures, edema and possibly bladder cancer.

What is rhabdomyolysis?
Rhabdomyolysis is a condition in which the patient's muscle fibers deteriorate and enter the bloodstream. It can result in kidney failure.

Read More Actos Lawsuit FAQs

Actos Side Effects Legal Help

If you or a loved one have suffered heart failure, bladder cancer, liver damage or other side effects while taking Actos, please click the link below to send your complaint to an Actos lawyer who will evaluate your claim at no cost or obligation.

Last updated on May-7-15

ACTOS SIDE EFFECTS LEGAL ARTICLES AND INTERVIEWS

Actos Bladder Cancer Settlement Could Cost Takeda $2.7 Billion
Actos Bladder Cancer Settlement Could Cost Takeda $2.7 Billion Washington, DC: In what has been described as perhaps the largest settlement for a pharmaceutical drug that actively remains on the market, Takeda Pharmaceuticals of Japan will set aside as much as $2.4 billion to settle upwards of 9,000 pending lawsuits alleging Actos bladder cancer. The settlement could actually cost Takeda $2.7 billion, once costs are factored in [READ MORE]

Actos Cancer Victims Get $2.4B Settlement
Actos Cancer Victims Get $2.4B Settlement Santa Clara, CA: A $2.4 billion settlement has been agreed between Takeda Pharmaceuticals USA Inc. and some 9,000 plaintiffs who filed personal injury lawsuits against the company, alleging it failed to warn of bladder cancer risks from taking its Type 2 diabetes drug Actos (pioglitazone hydrochloride). [READ MORE]

Actos Cancer Victims Could See A $2.2B Settlement
Actos Cancer Victims Could See A $2.2B Settlement Santa Clara, CA: Takeda Pharmaceutical Co., the maker of Actos (pioglitazone hydrochloride), has agreed to pay over $2.2 billion to settle outstanding personal injury claims. The lawsuits allege that Takeda's diabetes medication increases the risk for cancer in patients using the drug and that it had knowledge of this but failed to properly warn consumers [READ MORE]




READER COMMENTS

Posted by
Georgia
on
My mother had Congestive Heart Failure and was taking Actos years before she was diagnosed with CHF. She died Jan 12, 2015 with CHF. On Oct. 9, 2014, my mother went into cardiac arrest and went into a comma for three months. She had severe brain damage that was irreversible.

Posted by
Anonymous
on
spouse lost both retinas became totally blind-developed major heart condition requiring quadruple bypass surgery open heart almost lost her on the table-lastly developed colon-cancer stage three. The failure to blackbox warn as requied did not give me the care gave spouse an opportunity to ask for different drug to use. The end results constant bodily and mental strss will result in her death.

Posted by
Louisiana
on
I have recently been suffering with congestive heart failure, a mild heart attack and a severe loss in kidney function. I used actos for at least 16 years and was never monitored for any type of side effects. When I started having congestive heart failure my doctor took me off actos while in the hospital. That is when I was informed that I had a loss in kidney function. My kidneys are working at 30% right now. On June 29th I had a heart attack.

Posted by
Illinois
on
My husband deceased, leaving me with 2 minor children and many financial, mental and physical stresses. The inability to complete the Educational Grants process to get my daughters into High School and College, still poses problems. The Mortgage (Predatory) Life/Disability Insurance Fraud has caused me and my family irreparable harm.

Posted by
Louisiana
on
Heart attack(massive), stent placed in artery.

Posted by
Ontario
on
At the time of his death he was and had been taking Actos for more than a year and a half for diabetes. I lost my life partner of 18 years.

Posted by
Michigan
on
My husband died from a heart attack after taking actos for numerous years, he was 47.

Posted by
Virginia
on
My mother was on Actos for her diabetes and her kidneys shut down. She had to receive dialysis for the last year of her life. Her body became so weak from dialysis treatments. She passed away November 11, 2011.

Posted by
New York
on
My mother died at the age of 47, from multi-organ failure including heart failure and kidney distress after taking ACTOS for a little over one year. My mother had basic health issues, but not things to pass away in a matter of 4 weeks.

Posted by
Illinois
on
Congestive heart failure leading to a triple bypass

Posted by
Alberta
on
Muscle pain & severe cramps, sporatic dark urine, Heart disease, Kidney problems....

Posted by
Georgia
on
When i started taking Actos for my diabetes i begin to have swelling in my legs and feet which caused amputation of my toe and now im currently blind. I was Admitted in the hospitals for my kidneys and also chest pains.

Posted by
Nevada
on
According to recent tests, I have significant coronary artery blockage/s, which will require angioplasty, possible stents and maybe even open chest surgery to repair blockages.

Posted by
Oregon
on
I have polyneuropathy but was able to stand and get myself up
and down on my own. After taking Actos within one week I could
no longer stand on my own or keep my balance and fell several
times. My leg muscles became locked and I could not even turn
over in bed. Within one day of not taking the drug I could see
a remarkable differance.

Posted by
Missouri
on
While taking Actos I suffered feet and leg swelling and weight gain. That in turn led to me having to take a water/blood pressure medication to help reduce the swelling.

Posted by
Florida
on
My ejection fraction went down to 20% within two years of Actos treatment and I had to have a pacemaker with a defibrillator installed twice within a week's time because my heart is in such bad shape. Age 54.

Posted by
Nevada
on
My first husband died of heart failure in my arms within a short time of taking this medication for his diabetes. This medication is fatal and devastating!

Posted by
Texas
on
I went through congetsive heart failure according to my Doctor. I needed 4 stents in my arteries, my cholesterol had always been about normal or better. Also I needed a Cardiac Ablastion as I developed Atrial Fibulation. I am now 43 years old and find it odd that I developed heart problems so early in life.

Posted by
Tennessee
on
My Doctor prescribed Actos to help my insulin do it's job. I took it for 8 months. I began gaining weight and on June 27, 2008 911 was called because I could not breathe. I was hospitalized with congestive heart failure due to Actos, and I now have heart damage when I had none previously. The Hospital physician and Heart Specialist both said my Congestive Heart Failure was caused by Actos and under no circumstances was I to continue taking it.

Posted by
Minnesota
on
For two years husband has been on Actos. He has had two major diabetes incidents and has congestive heart failure disease. I've been his care giver for two years. He has been depressed, over-weight, lethargic, hallucinating, etc.
After stopping Actos all symptoms disappeared. He was almost committed.

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