Government Regulators Worldwide Express Concern Over Link between Actos Diabetes Drug and Bladder Cancer

The U.S. Food and Drug Administration, along with government agencies in several European countries, are warning about the increased risk for bladder cancer for patients using Actos to treat type 2 diabetes. Drug regulators worldwide are taking steps to protect the health and safety of Actos users and prevent further harm. Unfortunately, in many cases, it may be too late. Our drug recall lawyers are currently reviewing potential Actos lawsuits for users diagnosed with bladder cancer as a result of the manufacturer’s failure to warn about the cancer risk.

In June of 2011, the FDA announced a new cancer warning will appear on the labeling of the popular Actos diabetes drug. The warning stems from an ongoing study, which found that the risk of bladder cancer increases as Actos users increase the dose and duration of their medication. The longer the exposure and the higher the dose, the greater the cancer risk. Even users who took Actos for a year faced a 40 percent increased risk for bladder cancer, according to the study. Unfortunately, despite concerns that surfaced in September of 2010 of an increased risk of bladder cancer, drug manufacturer Tada Pharmaceuticals failed to take any steps to warn Actos users.

Actos cancer risk concerns are also plaguing European drug regulators. Just two days before the new FDA Actos cancer warning in the United States, French and German authorities banned use of the drug. A French study of more than 150,000 diabetes patients confirmed an increased risk for bladder cancer the longer Actos is used. German doctors were ordered to stop prescribing Actos, along with other pioglitazone-containing drugs such as Competact. In the wake of these Actos recalls, Canadian health officials recently announced their own safety review of Actos.

The strong connection between Actos and bladder cancer is especially frightening, since Actos is a popular diabetes drug used by more than 2 million patients in 2010. It was approved in 1999 to control blood sugar in type 2 diabetes patients, and eventually became Takeda’s best-selling drug with sales topping more than $3.4 billion. Actos sales increased significantly in recent years, after several studies suggested it may be safer than its competitor, Avandia. Avandia has been linked to an increased risk of heart attacks, congestive heart failure, and death. These serious side effects led the FDA to severely restrict Avandia use in 2010, making it available only to patients who failed therapy using Actos.

Avandia manufacturer GlaxoSmithKline faces thousands of personal injury lawsuits from Avandia users throughout the country, including a group of Illinois plaintiffs seeking more than $650,000 in damages. They allege that GlaxoSmithKline knew of the increased heart problem risk but failed to warn Avandia users. Our Illinois drug recall attorneys are appalled that doctors are replacing one dangerous drug with another for diabetes patients. The side effects of Avandia are well-known and potentially fatal, and the latest Actos research suggests that Actos users face just as serious a risk.

Fraud, misrepresentation, and negligence are just a few of the legal claims that Avandia users are making in lawsuits pending throughout the nation. Similar claims will be made by Actos users diagnosed with bladder cancer. The manufacturer of Actos failed to fully research the dangerous drug and failed to adequately warn users of potential bladder cancer risks. With the help of an experienced Actos attorney, Actos users may receive compensation for the harm they suffered.

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