Actos Bladder Cancer and Compensation

Actos is a drug widely used in the treatment of type II diabetes which has been linked to a significantly increased risk of bladder cancer in users. Men are at a higher risk for Actos bladder cancer than women and ongoing clinical studies have indicated that increased risk may be as high as 40% for patients that have taken this diabetes drug for longer than 12 months.

Actos Facts

Actos was released in 1999 and is the tenth most prescribed drug in the United States. It is manufactured by Takeda Pharmaceuticals and sales of Actos account for about 27% of the company’s revenue. One of the active ingredients is pioglitazone and this chemical is associated with an increased risk of bladder cancer in rats. Although initial preclinical trials did show the increased Actos bladder cancer risks, Takeda buried the information in their “Patient Package Insert” so most doctors and patients were not aware of the danger.

Clinical Study in France

Between 2006 and 2009, the French Medicines Agency conducted a study of 1.5 million individuals and found that patients taking pioglitazone had a significantly increased risk of developing bladder cancer. In response to this study, the French government banned the sale of Actos in the country. After reviewing the conclusions of the French study, the government of Germany banned the use of Actos for new patients (the German ban did not apply to patients already taking Actos) due to concerns about the link between pioglitazone and Actos bladder cancer side effects risks.

FDA Required Study

Kaiser Permanente Northern California is currently conducting a 10 year Actos bladder cancer study sponsored by Takeda and required by the FDA. The study was initiated in 2002 and the final results have not yet been published, but a 5 year interim analysis showed a 40% increased risk of bladder cancer in patients who took Actos for more than 12 months. There is no indication at this time that individuals who took Actos for less than 12 months have a significantly increased risk, although the report indicated men were at greater risk than women.

Symptoms of Bladder Cancer

Bladder cancer is an aggressive disease that often has no noticeable symptoms until it reaches the advanced stage. The most obvious symptoms are frequent or painful urination, blood in the urine and straining during urination. Other symptoms include fatigue, incontinence, bone pain and weight loss. In men, many of the symptoms are similar to those of enlarged prostate, so patients that have taken the diabetes drug Actos advise their doctor and ask for an Actos bladder cancer screening during their next physical exam.

Causes of Bladder Cancer

Medical researchers theorize that bladder cancer is caused by an increased concentration of toxic chemicals in urine. It is known that long term exposure to certain industrial chemicals, smoking tobacco and chemotherapy treatments increase the risk that an individual will develop bladder cancer. Bladder cancer is strongly associated with long term use of the drug Actos and is considered a signature disease. Individuals who developed Actos bladder cancer may have legal recourse based on current medical information.

Prognosis for Actos Bladder Cancer

In America, about 14,000 people a year die from advanced stage bladder cancer. The 5 year survival rate is less than 50%. Bladder cancer can metastasize to other areas of the body and it is a type of cancer that is frequently recurrent. Because early stage bladder cancer may have no symptoms or symptoms that are associated with other common conditions, it is often not diagnosed until the advanced stage when effective treatment is more difficult and less likely to cure the disease.

FDA Response

While the FDA required the 10 year Kaiser Permanente study, they have been slow to respond to the mounting evidence that links a significantly increased risk of bladder cancer to Actos. In June of 2011, the FDA announced that Actos would have to carry a cancer warning on their label and insert. Until the FDA announcement, Actos bladder cancer lawsuits had received limited response in U.S. courts, but the announcement has bolstered the claims of former Actos users.

Is Actos Still Sold in the U.S.?

The FDA did not place any restrictions on the sale of Actos in the United States and it continues to be widely prescribed for the treatment of diabetes. Following their announcement, the FDA did require an update in the warnings and precautions section of the diabetes drug label, but did not order an Actos bladder cancer black box warning for side effects. The black box warning is the strongest action the FDA can take before removing a drug from the market. The FDA stated they recognized the statistically significant relationship between Actos and bladder cancer, but that the link needed further investigation.

Actos Bladder Cancer Lawsuits

It is estimated that Takeda may face as many as 10,000 lawsuits from former users of the drug that developed bladder cancer. There are currently hundreds of pending Actos lawsuits in the federal court system and attorneys for Takeda and the plaintiffs filed a joint motion to move all the pending lawsuits into a single district court. The Multidistrict Litigation Judicial Panel in Georgia consolidated Actos lawsuits to the Western District of Louisiana on Dec. 30, 2011. All the cases in the MLD are for individuals who developed bladder cancer after taking Actos for more than 12 months.

Multidistrict Litigation

Multidistrict litigation is a method used by the federal court system to streamline the legal process and avoid duplication of legal motions and rulings between similar cases. The consolidation of Actos bladder cancer litigation is for the purposes of discovery and pre-trial motions and will not have any impact on individual plaintiffs. Trials will be held in the jurisdictions where the original lawsuits were filed and attorneys will handle the pre-trial discovery through the assigned district court.

Legal Compensation for Actos Victims

Anyone who has taken Actos for treatment of diabetes type II and developed bladder cancer may be entitled to legal compensation for medical expenses as well as pain and suffering. If a loved one died of bladder cancer after using Actos, survivors may be entitled to file a wrongful death claim for compensation of their loss. Individuals who believe they have grounds for a lawsuit should consult a lawyer specializing in Actos bladder cancer lawsuits as soon as possible since the time to file legal action is limited.

If you or someone you know has taken Actos for type II diabetes and developed bladder cancer, a free compensation evaluation of the case is available here on this website. Simply complete the short questionnaire and an experienced legal professional will contact you and assist you in finding a lawyer to handle your Actos bladder cancer case.

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