Actos is a dangerous drug that some of you or your family members might have taken that is associated with an increased risk of bladder cancer. If you have been on Actos for a year or longer and are now diagnosed with cancer, the manufacturer of the medication might be to blame. At the Law Offices Cytryn & Velazquez, P.A., we will do our best to see if your case is one we can help you with. The best step you can take is contacting a personal injury attorney to see if your cancer was possibly the result of taking Actos.
When you or someone you know is diagnosed with cancer, it is naturally devastating. But when you find out your cancer could have been avoided, it becomes even more frustrating. That is exactly what is happening to some of the people who are taking or have taken the medication Actos (pioglitazone). Actos is an oral drug that is prescribed to people who are diagnosed with type II diabetes. The drug is manufactured by Takeda Pharmaceutical Co. and has been around since 1999. Until recently, Actos was the leading diabetes drug in the world.
In June of 2011, the U.S. Food and Drug Administration (FDA) issued a warning that the use of Actos for a year or longer is possibly linked to an increased risk of bladder cancer. The FDA added that information about the increased risk of bladder cancer to the “Warnings and Precautions” section of the label on the Actos box. In order to further protect the public, two months later, in August of 2011, the FDA approved updated labels for Actos that warned “that healthcare professionals should not use pioglitazone in patients with active bladder cancer” and “should use pioglitazone with caution in patients with a prior history of bladder cancer.” These warnings are commonly referred to as “black box warnings.”
Other parts of the world also started taking measures to protect the public from harm from Actos as well. In particular, in 2011 France suspended the use of Actos entirely after the results of an epidemiological study that they conducted showed an increased risk of bladder cancer with Actos. Additionally, the French study found that the risk of bladder cancer increased with exposure to the drug longer than a year. Specifically, the risk of bladder cancer was significantly increased in people who had taken a cumulative dose of more than 28,000 mg of Actos (pioglitazone). Similarly, in Germany, they decided not to start new patients on the drug.
There have been various studies conducted concerning the increased risk of bladder cancer associated with the use of Actos. Researchers have found that there is a 20-40% increased risk of bladder cancer in patients who took Actos for 1 to 2 years. For those patients who took Actos for more than 2 years, research indicates the increased risk of bladder cancer could jump as high as 80%. There is also published medical research that indicates even low dose Actos use for six months or more causes an increased risk of bladder cancer in diabetics.
Despite the evidence of the studies conducted in France and the U.S., Takeda Pharmaceutical Co. backs up their drug. In fact, the company conducted their own industry funded study on Actos in 2005 and found that the link between Actos and bladder cancer did not reach a statistical significance. However, since the date of the study, major flaws have been found. For example, the study lacked relevant information such as tumors that appeared in patients within one year of entry into the study. In addition, the study left out people that had one or more risk factors of bladder cancer in their medical history.
Takeda Pharmaceuticals has generated significant revenue from the sale of Actos. According to Bloomberg, Actos sales at its highest totaled $4.5 billion annually, which equated to 27% of Takeda’s revenue around 2011.
Risk factors that increase the chances of bladder cancer include smoking (which is one of the biggest risk factors), industrial chemical exposure, chronic bladder irritations and infections, and chemotherapy and or radiation therapy. In 2009, the company revisited their study and reported that the drug did not cause bladder cancer and actually helps prevent cancer. However, independent researchers recalculated the data that was originally produced by the company to include risk factors and consequently, a significant link was found between Actos and bladder cancer.
Recently, a federal jury recognized the link between Actos and bladder cancer and held Takeda Pharmaceuticals and their marketing partner liable for not disclosing that risk. In April 2014, the federal jury awarded $1.5 million in compensatory damages and $9 billion in punitive damages for keeping this cancer link from doctors and patients.
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