(May 10, 2012) In July 1999, the U.S. Food and Drug Administration (FDA) approved the drug pioglitazone, manufactured by Takeda and Eli Lilly and Company, as Actos, to help treat type 2 diabetic patients.
A two-year animal study had shown tumors in male rats receiving doses of Actos that produced blood levels equivalent to those resulting from a clinical dose in humans. The drug was approved anyway, and was launched with no warnings about Actos bladder cancer. The manufacturers should have performed further testing prior to completing a New Drug Application.
In 2005, results of the PROactive three-year-study on ACtos were published in the journal Lancet. Researchers planned to look only at the potential cardiovascular results, however, during the study, they noticed a significant amount of Actos bladder cancer results in patients who were receiving Actos. But the researchers, as well as the drug makers, did not address the startling bladder cancer cases.
In September 2010, the FDA issued a safety announcement, stating that they were looking into a possible link between the diabetes drug and Actos bladder cancer. It was not until 2011 that the European drug agencies and the FDA began to recognize the dangerous Actos side effects and issued warnings to that effect.
On June 15, 2011, the FDA issued a safety announcement, informing the public that “use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” In 2011, authorities in France and Germany banned sales of the drug after extensive research. This was prompted by the results of an ongoing, ten year study, showing that patients on the drug for more than one year experienced a 40 percent increased risk of Actos bladder cancer.
New cases of Actos bladder cancer arise steadily. What is common in all of these cases is the question of why Takeda did not conduct further testing, after a two-year carcinogenicity study showed that the drug caused tumors in the urinary bladders of rats. Why didn’t Takeda report this information, and why in 2005 did Takeda executives dismiss a PROactive study showing that Actos users were at 2.5 times greater risk of developing bladder cancer than those taking other drugs to treat type 2 diabetes? Maybe because Takedas’ profits were more important to them than anything else, including the safety of innocent diabetics.
So many patients are suffering with bladder cancer, while many have lost their lives from this cancer. They all say that if they were told of the risks, they never would have taken this prescription. They would be better off with uncontrolled sugar than with bladder cancer or even death. The fact that this drug maker knew of the dangers of their drug and did nothing to protect the consumers is unacceptable and they must pay. It is estimated that the number of Actos lawsuits could reach over 10,000. Actos is currently being handled under MDL (multi-district litigation) by a US District Court in Louisiana.