In 2012, Takeda’s profit dropped 53% and net profit was down 14% in the last nine months of 2012.
Because medical studies have demonstrated the causal connection between Takeda’s flagship diabetes drug Actos and bladder cancer and Takeda also lost its exclusivity patent on its foundation product diabetes treatment. Actos accounted for more than half of Takeda’s U.S. revenue and 18% of its overall sales. At its peak, Actos brought in more than $3 billion and $16 billion total since its release in 1999.
For Takeda, losing Actos exclusivity in August 2012 was a tipping point in downward direction as Takeda confronted generic entries from Ranbaxy Laboratories and Mylan. But competition isn’t the only reason for flagging sales. Medical studies showing an association of Actos and bladder cancer as well as a “Black Box“ warning have also impacted formerly widespread use by diabetes suffers.
Additionally, in the case of Cooper vs. Takeda, a Los Angeles jury, after listening to all of the evidence found Takeda responsible for Mr. Cooper’s bladder cancer and awarded $6.5 million to Mr. Cooper only to have trial judge, the Hon. Kenneth Freeman, overturn the verdict. The case is now on appeal.
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Studies Demonstrate Dangers of Actos
A European study by the French Medicines Agency found a 22 percent higher risk of bladder cancer in approximately 155,000 patients taking Actos from 2006 to 2009, compared to 1.3 million patients not taking the drug. The risk was highest in patients taking a cumulative Actos dose of 28,000 mg or more during the study period. Authorities responded to the evidence of bladder cancer risk by recalling Actos in France and Germany.
In September 2010, the FDA ordered a safety review of Actos. In June 2011, the U.S. Food and Drug Administration issued a drug safety alert warning that the use of Actos for more than one year may be associated with an increased risk of bladder cancer. In August 2011, a report by eHealthMe based on FDA reports and the user community stated that of 22,512 people reporting side effects, 50 (0.22%) had bladder cancer. A May 2011 study of a half million diabetes drug Adverse Event reports to the FDA between 2004 and 2009 suggested a “disproportionate risk” of bladder cancer in Actos patients, finding that of patients reporting bladder cancer, one-fifth of these were taking Actos. In April 2012, Health Canada, the government drug safety agency for Canada, issued a safety warning on Actos.
Takeda is facing more than 3,000 suits alleging Actos caused bladder cancer or other ailments, according to court records in both MDL No. 2299 before the Hon. Rebecca Doherty and in California and other states. The first MDL bellwether trial is set for January 27, 2014.
If you or a loved one has been diagnosed with bladder cancer and took the diabetes drug Actos, you may have a claim for your injuries. Thomas J. Brandi and the Brandi Law Firm are leaders in nationwide pharmaceutical litigation for decades and is now representing clients who have suffered bladder cancer related to Actos use and filed suits on their behalf. For a free consultation call us at 1-800-481-1615 or email us.