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CMAJ: Actos Increases Risk of Bladder Cancer by 22%
A new meta-analysis published in the Canadian Medical Association Journal (CMAJ) on July 3rd found that Actos increases the risk of bladder cancer. This study follows studies in the Diabetes Research and Clinical Practice Journal and BMJ which also found that Actos is linked to an increase in the risk of bladder cancer.
The CMAJ study examined 10 different studies on that thiazolidinediones, the class of drugs that includes Actos, with a total of 2.6 billion patients who took Actos including 3,643 people who were newly diagnosed with bladder cancer after taking Actos.
The CMAJ study found that thiazolidinedionesin general increase the risk of bladder cancer but found that Actos in particular increases such risk with Actos being associated with a 22 percent increase in the risk of bladder cancer according to Jeffrey A. Johnson, one of the authors of the study and a anada Research Chair in Diabetes Health Outcomes at the University of Alberta School of Public Health, in Canada.
Nick Bruno is a Legal Assistant at Thompson & Tredennick
Study Shows Actos Increases Risk of Bladder Cancer
A new meta-analysis of existing studies on Actos and bladder cancer published in the Diabetes Research and Clinical Practice Journal found an increased risk of bladder cancer.
The new meta-analysis follows a British Medical Journal study finding that Actos increases the risk of bladder cancer. The meta-analysis examined five studies with a total of over 2,350,000 patients. The result of the study included findings that Actos can “significantly increased risk of bladder cancer in patients with diabetes.”
Thompson & Tredennick partner Joel Thompson comments, “This comprehensive, in-depth study simply confirms what we have feared for some time. Individuals suffering from Type II Diabetes, who are taking Actos, should immediately consult their physician in order to determine whether or not they should continue.”
Nick Bruno is a Legal Assistant at Thompson & Tredennick
New Study Finds Actos and Avandia May Increase Risk of Vision Problems
A recent study published in the Archives of Internal Medicine suggests that use of thiazolidinediones, a class of drug used to treat Type 2 diabetes which includes Actos and Avandia, may increase the risk of vision problems.
The study followed 103,000 people for ten years and found that:
- Participants taking one of the medications were two to three times more at risk of developing macular edema, a swelling in the center part of the retina which can lead to blindness (although the likelihood of developing the disease was relatively small)
- 1.3% of participants taking one of the medications developed diabetic macular edema, compared to a rate of 0.2% among participants not taking either medication
- Combining the drugs with insulin further increased the risk
However, because Actos and Avandia are often secondary treatments for Type 2 diabetes, the study’s findings may, to an extent, reflect more serious cases of diabetes in people taking the drugs.
Iskandar Idris, one of the study’s authors and a consultant in diabetes and endocrinology at Sherwood Forest Hospitals Foundation Trust in England, speculated that the drugs may cause damage to the retina because of greater sodium and fluid retention or changes in blood vessels. Dr. Idris suggested that people taking one of the drugs should have their vision checked regularly, especially if they’re also taking insulin or have a history of visual issues.
Kelsey Tissue is a Law Clerk at Thompson & Tredennick
Drug Recalls Continue to be a Problem
In a recent interview with ABC News, Dr. Steven Nissen addressed the fact that drug recalls continue to be a problem in the United States. Nissen criticized the regulatory process as being “far from perfect,” explaining that, “some drugs make it on the market without adequate information about their safety and efficacy.” Central to the problem is the surveillance system to determine unsafe drugs which, according to Nissen, is of “very poor quality.” Further, reporting to the FDA is only voluntary–practitioners are not required to report patients with serious adverse effects to a drug. According to Nissen, only 1-10% of all serious adverse effects are reported; the result is that “many drugs don’t get recalled until they cause considerable harm.”
Surprisingly relevant to his criticisms of the surveillance and reporting systems is Nissen’s alleged recent involvement in Takeda Pharmaceutical Company’s apparent violation of the Federal False Claims Act. In 2007, Nissen published a study finding an increased risk of acute myocardial infarction and cardiovascular death in patients prescribed Avandia, a diabetes drug manufactured by GlaxoSmithKline. According to the federal government, Nissen’s study encouraged increased reporting of adverse effects of Avandia which allowed Takeda to market Actos, a similar diabetes drug, as the safer alternative. The government alleged that Nissen’s 2007 study and the fact that he stood to profit financially by directly attacking Avandia since, at the time the study was published he was serving as the principal investigator of a Takeda-sponsored trial to show Actos lowered cholesterol, combined with Takeda’s failure to report adverse events in patients taking Actos, led to Actos’ fraudulent domination of the prescription drug market for type II diabetes treatment.
Kelsey Tissue is a Law Clerk at Thompson & Tredennick
New Study Find Actos Increases Risk of Bladder Cancer
Another study finds Actos leads to an increased risk of bladder cancer.
After previous studies found that taking Actos increases the risk of bladder cancer, the new study published in BMJ found that patients taking Actos had were 83% more likely to develop bladder cancer than those who never took Actos. At the same time, those taking Avandia had no such increase in the risk of bladder cancer. The risk of developing cancer increased the longer patients took Actos.
Following previous studies which showed the risk of Actos, the FDA required Takeda, the manufacturer of Actos, to post a warning on Actos. Takeda faces 10,000 lawsuits from those who have claimed they have suffered bladder cancer as a result of taking Actos.
Thompson and Tredennick partner Ted Tredennick comments on the new study, “Again another study confirms what, according to whistleblower Dr. Helen Ge, Takeda has known all along: Actos causes bladder cancer.”
Nick Bruno is a Legal Assistant at Thompson & Tredennick
Takeda Acknowledges Link between Actos and Bladder Cancer
Actos (also known as pioglitazone), an oral diabetic medication, is prescribed to help people with type 2 diabetes control their blood sugar levels. Actos is a popular diabetic medication with over 2.3 million prescriptions in 2010 alone. Many patients taking Actos were convinced by aggressive marketing campaigns conducted by the manufacturer of Actos, Takeda Pharmaceuticals, that Actos was safer than other prescription alternatives.
However, the fact is that the opposite is true. Numerous studies show a strong link between Actos and an increased risk of bladder cancer.
Last week, in a major development in the pharmaceutical industry, Takeda pharmaceuticals acknowledged a link between Actos and bladder cancer. In a letter dated April 16th addressed to medical doctors in Canada, Takeda writes “findings from new studies reveal that there is a potential increased risk of bladder cancer in patients treated with pioglitazone-containing products.” The letter mentions a number of studies that have demonstrated a link between Actos and bladder cancer.
According to the letter from Takeda, factors that increase the risk of contracting bladder cancer while taking Actos include smoking, a family history of cancer, a past personal history of cancer, and chemical exposure.
This letter follows statements from Health Canada, the regulation arm for pharmaceuticals in Canada, that warn of the increased risk of contracting bladder cancer after taking Actos.
Nick Bruno is a Legal Assistant at Thompson & Tredennick
