Despite Personal Injury Lawsuits, Double-Blind Study Shows No Bladder Cancer from Generic Actos
The generic form of Actos, pioglitazone, was approved for use by the FDA last August. The approval caused a huge outcry from Actos opponents, including many who are plaintiffs in personal injury lawsuits against Takeda Pharmaceuticals after taking name-brand Actos and developing bladder cancer.
Several studies since 2011 have shown a link between name-brand Actos and an increased risk of bladder cancer, especially if the patient takes the drug for two or more years.
However, a 3-year study from 2005 to 2008 into pioglitazone use – the generic form of Actos – showed no instances of bladder cancer.
The study involved a randomized, double-blind trial of more than 400 participants. In one arm of the study, 203 participants received a placebo pill and made lifestyle changes, such as diet and exercise. The other arm of the study, with 204 patients, took a 30 mg dose of pioglitazone and also made lifestyle changes. At the end of the study, there were two reports of cardiac events, but not a single report of bladder cancer.
Name-brand Actos has been so strongly linked to bladder cancer that France and Germany both banned the sale and prescription of the drug, and the US has put the strongest possible warning label on the drug. So the lack of link in this study between generic Actos and bladder cancer is very surprising.
India To Discuss Actos Ban
The study was conducted in India, and has become a piece of evidence used by doctors who want the ministry to overturn their June ban on Actos.
Doctors also point out that, while pioglitazone is somewhat cheaper than Actos, there are no other alternatives to treat Type 2 diabetes that are less expensive. They have also shown that Indian health ministry officials banned Actos “without following due process and scientific enquiry.”
The ministry will meet on July 19th to discuss the ban and scientific evidence both for and against the use of Actos and pioglitazone.
“This drug is in use in most advanced markets of the world, be it the US, Japan or the UK. I believe the DCGI has invited comments and responses from the industry and it should come up for review, which would be a very welcome step,” Lupin group president, India and CIS (Commonwealth of Independent States) Shakti Chakraborty told Business Standard.
The Strom Law Firm Can Help with Personal Injury and Wrongful Death Cases, Including Against Actos
If you or a loved one have taken Actos to treat Type II diabetes, and have since suffered dangerous side effects including developing bladder cancer, heart disease, liver failure, or diabetic macular edema, you may be entitled to compensation. The attorneys at the Strom Law Firm can help with personal injury and wrongful death cases, including against Actos manufacturer Takeda Pharmaceuticals. We offer free, confidential consultations to discuss the facts of your case, so do not hesitate to contact us. 803.252.4800