Though it was one of the most commonly prescribed drugs just five years ago, thousands of people who once took Actos have filed a lawsuit against the drug’s manufacturer after experiencing severe side effects. The vast majority of these cases have been filed because the medication is now believed to result in a higher risk of bladder cancer. The manufacturer, Takeda Pharmaceutical Company, has responded to some of this research negatively and pressured judges to throw out cases against the company.
The primary ingredient in this medication is pioglitazone, a substance effective in the treatment of type 2 diabetes. It has hypoglycemic properties and selectively activates the peroxisome proliferator-activated receptor (PPAR) protein, which serves as a nuclear receptor in the body. When activated, pioglitazone changes the expression of insulin-sensitive genes, resulting in reduced insulin resistance in the liver. It also reduces the concentration of glucose in the blood and increases the rate at which this glucose is expended. Together, this helps prevent some of the most profound effects of diabetes and helps maintain homeostasis in the body.
However, this treatment may come at a high cost. A former medical reviewer for Takeda has revealed that the company set out to market its anti-diabetic medication as safer than its chief competitor at the time, GlaxoSmithKline’s Avandia. To achieve this, the medical reviewer claims that Takeda doctored its safety reports to make the drug appear safer than it really was, primarily by misidentifying serious side effects in the Federal Drug Administration’s (FDA) Adverse Event Reporting System. As a result, some of the more serious complications, like congestive heart failure or bladder cancer, were not properly classified in the database as “serious.”
Many people who have taken Actos and filed a lawsuit have done so in response to the poor safety reports regarding bladder cancer. In fact, several cases have already gone to trial regarding pioglitazone’s linkage to the disease. In 2011, the French National Health Insurance, a national medical research institution, released the results of an epidemiological study of patients on pioglitazone for several years. What they found was that patients who were on the drug for an extended period of time were more likely to suffer from bladder cancer. Takeda’s own safety research did not demonstrate these same results. The FDA has also reviewed five years of data regarding patients on pioglitazone and has found that there is a higher incidence rate of bladder cancer among patients taking the drug long term. In response to this data, the FDA has required Takeda to include safety warnings on the drug’s packaging.
Most of the people who have taken Actos and filed a lawsuit against Takeda allege that the company was negligent in its manufacturing, testing, and marketing of the medication. Takeda has responded by claiming the results of the current safety research are flawed and have pushed for judges to reject cases involving the drug. Regardless, thousands of people have joined together in a class action lawsuit, and people affiliated with the case have stated that many of these cases will go before a judge soon.
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Anyone who has taken pioglitazone and suffered from serious adverse effects like bladder cancer should consider speaking to a drug injury attorney. After consulting with an experienced legal professional, a victim will know what their options are regarding compensation for their suffering.