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Steve Thomas
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Actos bladder cancer risk stimulates global scientific inquiry

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The scientific world has been revisiting that which previous studies have concluded, courts have recognized, and patients in Actos lawsuits have personified: the increased risk of bladder cancer associated with taking the diabetes medication.

Apparently, Actos side effects can be so serious, and type-2 diabetes is sufficiently prevalent, so as to stimulate global scientific inquiry.

Summaries of some of these Actos (pioglitazone) studies were published in December and in January. Indeed, if these works had been churned out on the old schoolhouse ditto machines, we could still smell the ink’s peculiarly alluring scent on these reasonably fresh writings.

For instance, an article in the December 2012 edition of Korea’s Diabetes & Metabolism Journal explained the findings of a recent study showing “that the risk of bladder cancer in Korean diabetics treated with pioglitazone might be different from that of other ethnicities,” a disparity that is worthy of further examination.

Then Dr. Sang-Yong Kim replied to the Korean study in his published letter, writing that the science “is unable to clearly exclude the possibility of a relationship between pioglitazone and bladder cancer.” Moreover, he wrote, “Because the authors are currently analyzing the data from 3,500 patients with bladder cancer across several university hospitals, this result will provide a more definitive conclusion about the relationship between pioglitazone and bladder cancer in Korean diabetic patients.”

The Swiss contributed to the empirical discourse in the January 2013 edition of the Expert Opinion on Drug Safety. The article centered on the effectiveness and safety of peroxisome proliferator-activated receptor drugs as well as fibrates and glitazones. Actos is one of the latter.

The authors suggested that the safety considerations of Actos may necessitate supplemental investigation of the safety of the next generation of these drugs, ideally leaving no stone unturned in protecting the patient. They wrote, “The emerging data on the possibly increased risk of bladder cancer with pioglitazone may prompt the need for post-approval safety studies for new drugs.” That observation alone speaks to the potentially far-reaching impact of the association between Actos and bladder cancer.

The Dec. 7 edition of an international journal for health care providers, Diabetes Research and Clinical Practice, also tackled and confirmed the relationship between Actos and bladder cancer. The abstract of a study that monitored Japanese patients read, in part, “We retrospectively examined the frequency of bladder cancer in Japanese patients with type-2 diabetes in relation to use of pioglitazone. Among a total of 663 patients identified to be taking pioglitazone, 9 had bladder cancer (1.36 percent). … However the prevalence of bladder cancer was 2.10 percent in patients taking pioglitazone for less than 24 months which was significant[ly] increased.”

The January 2013 British Journal of Clinical Pharmacology noted a study that showed no statistically significant association; nevertheless an association did exist. The pioglitazone group still had a higher rate of bladder cancer per 100,000 person years.

This article centered on a United Kingdom database study conducted between 2001 and 2010 that monitored two unequal cohorts of patients who were at least 40 years old. There was a pioglitazone treatment group and another larger group that was treated with other drugs. The authors wrote, “Thirty-nine and 48 new cases of bladder cancer were recorded for the pioglitazone treatment group and the other hypoglycaemic drugs treatment group during mean follow-up times of 3.2 (2.7) and 4.2 (3.6) years, respectively. The event rates were 76.0 per 100,000 person-years for the pioglitazone treatment group and 71.3 per 100,000 person-years for the other oral hypoglycaemic drugs treatment group.”

An observation can be made about these recent studies that are centered on the efficacy and adverse reactions of this Takeda medication. There is an aspect of these inquiries that must not be buried underneath an avalanche of analysis. Statistics are not the only matters evaluated based on their “significance.”

If you are or were an Actos patient who has been diagnosed with bladder cancer, you may be entitled to compensation. You deserve to recover damages because, statistical significance notwithstanding, your bladder cancer diagnosis is significant. The unreasonable risk of Actos is significant. The manufacturer’s failure to adequately warn about the increased risk is, without a doubt, significant.

Just saying.

The Actos attorneys at Reich & Binstock [www.reichandbinstock.com] want to help. The experienced pharmaceutical injury attorneys at Reich & Binstock will fight for you, in essence, because your well-being and your right to compensation are indeed significant.

Actos victims who have been diagnosed with bladder cancer, no matter their state of residency, may want to contact an Actos lawyer at Reich & Binstock for a free consultation. At Reich & Binstock, it costs nothing to receive legal advice as to the viability of an Actos lawsuit or another compensatory option. The toll-free number is 1-866-LAW-2400.

Shifting now to a domestic regulatory perspective, the U.S. Food and Drug Administration had something to say nearly two years ago about the totality and criticality of Actos studies. The FDA changed the Actos warnings consistent with available evidence of the increased risk of bladder cancer in those who would take the drug for more than a year.

This is a part of the June 15, 2011, FDA statement: “The U.S. Food and Drug Administration is 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. Information about this risk will be added to the Warnings and Precautions section of the label for pioglitazone-containing medicines. The patient Medication Guide for these medicines will also be revised to include information on the risk of bladder cancer.”