In June 2011, the FDA required a change to be made to the Actos label reflecting a 40 percent increased risk of bladder cancer for those who take Actos for more than one year. This announcement was based on the FDA’s review of an ongoing, ten-year study. The FDA also recommended that medical professionals not prescribe Actos to patients with bladder cancer or with a prior history a bladder cancer.
At the same time, results surfaced from a study conducted in France, which also linked Actos use with an increased risk of bladder cancer. As a result, use of Actos has been suspended in France, and Germany has advised doctors not to start any more patients on Actos.
In August 2011, the first lawsuits were filed against Actos manufacturer Takeda Pharmaceuticals blaming the diabetes drug for instances of bladder cancer. Victims are suing for financial compensation for the cost of hospital bills and loss of income, as well as physical and emotional suffering. Legal experts predict that these are the first of many Actos lawsuits that will be filed.
In 2007, amidst an intense debate over the safety of Type-2 diabetes drugs, the FDA asked the makers of Actos to issue a black box warning about the serious risk of adverse cardiovascular events, including heart attack, heart failure and cardiovascular-related deaths. A black box warning is the strongest FDA-requested label change that can be added to a drug.
If you are taking Actos and are concerned about the risk of bladder cancer posed by this medication, it is important to speak with your healthcare provider. Remember, it is crucial to speak with a qualified physician before changing your treatment regiment or stopping Actos. Patients who choose to continue use of Actos should be made aware of the possible side effect risks and the symptoms of these complications.
If you or a loved one has been diagnosed with bladder cancer after taking Actos for more than one year, you may be able to seek compensation for the associated physical, financial and emotional suffering. Please contact the qualified Actos attorneys at Oshman & Mirisola to learn more about your legal rights and options. We offer a free, no-obligation consultation during which we will evaluate your case and determine the best way to help you and your family.
Oral diabetes medication Actos (generic: pioglitazone) is made by Takeda Pharmaceutical Company and co-marketed in the United States by Eli Lilly Pharmaceuticals. Actos is used to control type-2 diabetes in patients whose condition is not adequately controlled by diet and exercise alone. Actos belongs to a class of drugs called Thiazolidinedione drugs, which work to lower blood glucose levels and increase the body’s sensitivity to insulin. Pioglitazone may be prescribed alone (as Actos) or in combination with other active ingredients such as metformin (sold as Actoplus Met) or glimepiride (sold as Duetact). A patient’s drug regiment may also include insulin or other medications in addition to those containing pioglitazone.
Actos has been favored for its once-a-day dose and its success with controlling blood sugar. Once competing drug Avandia was linked to serious risk of heart attack in 2006, Actos’ popularity quickly increased and sales had climbed from $2.9 billion to $4.3 billion by 2010. Sales are likely to take a hit with the revelation of the research linking long-term Actos use to bladder cancer.