Actos History: From Diabetes Treatment to Cancer Side Effects & Lawsuits
By Andrea Gressman
Actos, manufactured by Takeda Pharmaceuticals, is a drug that was developed to combat type 2 diabetes. Unfortunately, it has had a litigious history filled with Actos lawsuits and class action lawsuits for multiple adverse side effects and accusations of hiding some side effects from the FDA all together. As the Actos lawsuit litigation against Takeda progresses, with a court date now set for November 2014 in the federal MDL, here is an overview of the checkered history of this volatile drug.
Actos Receives FDA Approval
The FDA approved Actos in 1999 for the use of patients with type 2 diabetes. The drug worked by improving the glucose control in patients who had trouble with blood sugar management using just diet and exercise and was often used in conjunction with other medications like insulin and metformin. For the first few years, there were no reported issues with Actos but extended use of the drug has now been linked to several health issues.
Actos Side Effect Reports Start Being Filed and the FDA Requires Actos to Use a Black-box Warning Label
In 2002, the first serious reports of adverse side effects of Actos surfaced. Actos was found to contribute to an increased rate of congestive heart failure in patients with cardiac conditions. Edema was a frequent result of Actos use, which can intensify the pre-existing heart problems patients had as they started use of the drug. Hard numbers are not available for the number of patients affected by this Actos heart side effect. However, future lawsuits against Takeda have cited this. The link was strong enough that in 2007, the FDA upgraded Actos to their most extreme warning to highlight the risk of heart failure: the black-box.
Additional Actos Side Effects Come to Light
The troubles with Actos were far from over. In 2008, a study found that the side effect risk of fractures doubled in post-menopausal women. While the exact mechanism by which the side effect risk is increased is unknown, it is suggested that it activates a particular receptor called PPAR-gamma. This receptor increases the impact of insulin but also slows the formation of new bone. Increased fractures were often seen after a year of use of Actos and most often occurred in the lower arms and legs as well as the hips of patients. This adverse side effect has also been the subject of Actos lawsuits against Takeda.
And Still More Actos Side Effects Surface
The year 2009 brought more bad news for Takdea as Actos was found to double the side effect risk of macular edema that can cause reduced vision and blindness in users. This is related to the increased rates of heart failure mentioned above as this was caused by the onset of edema with use of Actos. This edema, located in the eye, causes the related vision issues cited in the study.
Study Revealed Actos Increases Side Effect Risk of 40% for Bladder Cancer
The most damning evidence against Actos came in June of 2011 when the FDA declared that Actos can increase the risk of bladder cancer by as much as 40% for anyone who used the drug for more than one year. In the same month, France and Germany banned the drug because of the bladder cancer side effect. The bladder cancer revelation really accelerated Actos lawsuit litigation against Takeda with the first Actos class action lawsuit being filed in September of 2011 and others combined into multi-district litigation in December. In May of 2012, the judge permits patients to join the Actos lawsuit directly by filing against Takeda directly with the court in Louisiana.
Takeda Faces Additional Actos Lawsuits for Hiding Adverse Side Effects from the FDA
March 2012 brought fresh problems for Takeda, this time from former employee Dr. Helen Ge. Suing Takeda under the False Claims Act, Ge alleged the Takeda knowingly hid the knowledge of the listed adverse effects of Actos from the FDA. The story of Actos litigation is long and is set to continue as the first test trial will take place in federal MDL in November of 2014.
If you were a victim on one of the many negative Actos side effects, including bladder cancer, visit the Actos Bladder Cancer Class Action Lawsuit Investigation page. Discover what your legal options are from a qualified Actos lawsuit attorney.
Updated November 23rd, 2012
All medical device, dangerous drug and medical class action and lawsuit news updates are listed in the Drug and Medical Device section of Top Class Actions.
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