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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.
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.
Actos Heart Attack Link
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.
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.
Actos Rhabdomyolysis & Actos Kidney Failure
Rhabdomyolysis 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 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.
Actos 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.
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 FDA Warning
Actos is used to treat type 2 diabetes, sometimes in conjunction with insulin. It was initially approved for use in 1999.
What is Actos?
Actos Lawsuit FAQ
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 HelpIf 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