New Lawsuit Says Takeda Deliberately Concealed Evidence of Actos Side Effects
A Connecticut resident has joined the list of plaintiffs across the country who have filed Actos lawsuits. Plaintiff Fernando Olavarria was diagnosed with bladder cancer after taking diabetes drug Actos for more than a decade accuses manufacturer Takeda Pharmaceucials of deliberately concealing evidence of Actos side effects.
Olavarria, through his Actos lawyer, filed his lawsuit against Takeda Pharmaceuticals in the Circuit Court of Cook County, Illinois on April 2, 2012. Olavarria was first prescribed Actos in or around May 1999. He was diagnosed with bladder cancer in August 2010 and discontinued Actos use in September 2011. His Actos side effects lawsuit states that he would not have taken the drug if the defendants had properly disclosed the risks of its long-term use.
The lawsuit states that Olavarria has been “permanently and severely injured,” that he requires ongoing medical care and treatment, and that he has suffered severe mental and physical pain and suffering, emotional distress, and economic loss due to medical expenses.
Actos lawsuits cite study findings on cancer risk
As with other plaintiffs who have filed Actos lawsuits, Olavarria points out that many studies have shown the link between Actos and bladder cancer, including studies that were done before the FDA approved the drug in 1999. For example, a two-year study conducted on male and female rats found that tumors developed in male rats that received doses of Actos equivalent to a clinical dose of the drug in a human.
In 2005, a three-year study focusing on cardiovascular Actos side effects unexpectedly found that patients taking Actos had a higher incidence of developing bladder cancer than patients taking other drugs.
However, this evidence of life-threatening Actos side effects was never made public by the defendants, who the lawsuit charges, “willfully, wantonly, and with malice withheld the knowledge of increased risk of cancer in users of Actos to prevent any chances of its products’ registrations being delayed or rejected by FDA.”
FDA reacts to increasing number of Actos lawsuits
In 2010, in reaction to the growing number of Actos lawsuits, the FDA reviewed data from the five-year mark of an ongoing 10-year Actos study and found the risk of bladder cancer increased with the dosage and length of usage. In 2011, the FDA added a bladder cancer warning to the Actos label and reported that patients who used Actos for more than one year had a 40% increased risk of bladder cancer.
That same year, an Actos recall was issued in France, while Germany suspended sales of the drug. Despite growing numbers of Actos lawsuits, and reports from patients abour devastating Actos side effects, Takeda has never issued an Actos recall in the United States.