Florida Actos Attorneys
Actos received U.S. Food and Drug Administration (FDA) approval in 1999 to treat type 2 diabetes in adult patients. While many patients have been satisfied with the results, a number of patients have experienced deadly side effects from the drug. These side effects include bladder cancer, bone fractures, and heart and liver failure. Studies show that these side effects are most prevalent in users who have taken Actos for longer than one year. A number of users have filed an Actos lawsuit to recover financial compensation for the harm that the drug caused.
Actos Bladder Cancer
By 2011, more than ten thousand patients filed a bladder cancer lawsuit against the manufacturer, Takeda Pharmaceutical Company. Alarmingly, an ongoing interim study suggests that Actos patients who took the drug for two years or longer had a roughly 40 percent increased risk of developing bladder cancer. Experts theorize that the drug may have carcinogenic properties – which are passed through the bladder on a daily basis in Actos patients – that contribute to the development of bladder cancer.
Patients who develop bladder cancer may experience symptoms such as:
- Consistent need to urinate
- Bloody urine
- Abdominal or lower back pain
- Painful urination
Other Actos Side Effects
Since the drug’s release, millions of patients have taken Actos, and a large number of patients have reported severe and potentially deadly side effects. These side effects include congestive heart failure, liver failure, and bone fractures. Patients have also reported the development of macular edema, a condition which causes swelling in the macula, which is located in the back center of the eye. Macular edema patients experience blurred vision, decreased visual quality, and blindness in severe and untreated cases.
Congestive Heart Failure
Congestive heart failure is also referred to as simply heart failure. The condition causes the heart to become unable to pump blood adequately through the body. In severe and untreated cases, death can occur. Due to severity of congestive heart failure, the FDA has issued a black box warning for the condition. This is the sternest warning, and it takes its name by a black outline that appears around the warning itself on the product’s label.
Actos users have also reported liver failure. For this reason, Actos patients are recommended to receive regular monitoring of liver enzyme levels during the course of their treatment, as liver enzymes can be a powerful indicator of liver failure. Actos patients should seek immediate medical attention and consider discontinuing Actos if they experience jaundice, or the yellowing of the skin and eyes.
Despite lobbying by a number of individuals and groups, Actos has not been recalled in the United States. However, Actos was recalled in Germany and France after a French Medicines Agency safety review. The safety review indicated that Actos created a 22 percent increased risk of developing bladder cancer in comparison to patients who used other type 2 diabetes medications. In conjunction with the recall, France and Germany have banned doctors in these countries from prescribing Actos patients.
Actos FDA Warning
In 2011, the FDA released a Drug Safety Communication warning the public of the heightened risk of bladder cancer in Actos users who take the drug for longer than a year. In addition to the formal safety communication, the FDA required that bladder cancer became listed in the drug’s “Warnings and Precautions” section of the label. During the same year, a black box warning was also required to warn consumers of the potential risk of developing congestive heart failure in patients.
Claims against Actos Manufacturers
There exist a number of legal claims against Takeda and Eli Lilly, including:
- Failure to warn consumers of the increased bladder cancer risk
- Misleading the public regarding health and safety concerns
- Manufacturing a defective and unsafe product
- Failing to implement proper testing of the safety of Actos
- Selling the drug despite the manufacturer’s knowledge that it is dangerous
- Concealing research and testing from the public eye
- Breaching warranty through the sale of a drug that’s potentially unfit for its use
Azoulay, Laurent, Hui Yin, Kristen Filion, Jonathan Assayag, Agnieszka Majdan, Michael Pollak, and Samy Suissa. “The use of pioglitazone and the risk of bladder cancer in people with type 2 diabetes: nested case-control study.” British Medical Journal Group. (2012): n. page. Web. 10 Oct. 2014. <http://www.bmj.com/content/344/bmj.e3645>.
Steenhuysen, Julie. “Actos, Avandia heart failure risks confirmed-study.” Reuters. Reuters, 27 Sept 2007. Web. 10 Oct 2014. <http://www.reuters.com/article/2007/09/27/idUSN27340425>.
United States. Food and Drug Administration. FDA Drug Safety Communication: Ongoing Safety Review of Actos (pioglitazone) and Potential Increased Risk of Bladder Cancer After Two Years Exposure. Web. 10 Oct 2014. <http://www.fda.gov/Drugs/DrugSafety/ucm226214.htm>.