This impending flood of filing in several states of America began, when the US-FDA issued a warning about Actos and bladder cancer in June 15, 2011. This FDA safety announcement informed public and healthcare professionals that use of Actos for more than a year might lead patients to greater risk of developing bladder cancer. For this announcement, FDA reviewed data from a five-year analysis of an ongoing ten-year epidemiological study. In addition, this review showed that patients who were taking Actos for longer than 12 months developed the risk of bladder cancer up to 40% compared to patients who never being exposed to Actos.
After this safety announcement from FDA, in August 2011, the first Actos lawsuit over bladder cancer was filed against the manufacturer (Takeda Pharmaceuticals) and co-marketer (Eli Lilly Pharmaceuticals) on behalf of a woman named Nancy Rios, 54, and she filed her Actos lawsuit due to recurrent bladder cancer. She stated that she was using this drug to aid in type II diabetes mellitus for more than a decade, and first diagnosed with cancer in 2009. In her lawsuit, she also stated that she had her second operation to remove bladder tumors in June, and she was anxious that she might lose her bladder.
She alleged that both the manufacturer and co-marketer are legally responsible for improperly warning patients and doctors about the possible risk of developing bladder cancer with Actos.
However, this suspected drug of Takeda pharmaceuticals got approval from the US-FDA in July 15, 1999, and soon after approval, Actos became one of the highly recommended drugs by physicians due to its cardiovascular safety profile as compared with its class member Rosiglitazone (Avandia).
According to Associated Press, when another popular drug of type II diabetes mellitus (Avandia) was restricted in U.S. market and withdrawn from Europe for developing the increased risk of heart attacks, Actos became the no. one diabetes pills in terms of diabetes medication sales. Despite, On August 14, 2007, the US-FDA informed that all the Pioglitazone containing products (Actos, ACTOplus met, ACTOplus met XR, and duetact) of Takeda Pharmaceuticals might cause or exacerbate congestive heart failure, but it didn’t affect on sales of Actos. In addition, the sales of Actos mounted from roughly $2.9 billion in 2006 to over $4.3 billion previous year.
Nevertheless, the huge sales of Actos jump down this year when the two European country France and Germany suspended sales of the drug in their market. This decision was based on the results of an epidemiological study. The epidemiological study followed approximately 155,000 Actos users over a three-year period between 2006 and 2009, and the study found an increased risk of bladder cancer with the long-term use of the medication.
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