What is Actos?
Actos, manufactured by Takeda Pharmaceuticals, is also referred to as pioglitazone and is used to treat Type 2 diabetes.
A number of very serious side effects have been linked to use of Actos, and these side effects are even more prevalent in those pre-subjected to heart conditions of kidney problems.
Actos is a prescription medication that is used to help blood sugar levels in the body. Actos works by increasing the body’s sensitivity to insulin in patients who suffer from Type 2 Diabetes, and be allowing the body to better use the insulin already in its system, it attempts to prevent sugar from building up in the blood stream.
Actos Side Effects
Very serious side effects have been reported due to use of Actos. An in-house study was done by Takeda Pharmaceuticals about the potential dangers of Actos, and following a 5-year study, the Food and Drug Administration announced a warning that individuals who have taken large doses of Actos over a period of years is at a far greater risk of developing a variety of potentially aggressive and fatal side effects.
In June 2011 Actos had sales suspended by medical regulators in both France and Germany due to the increased risk of developing bladder cancer, which is an extremely aggressive form of cancer. These decisions came on the back of a study done by the French Medicines Agency that showed diabetics taking Actos were at a 22% higher chance of getting bladder cancer than diabetics taking other drugs to combat their diabetes. Risk of bladder cancer was highest amongst those who had taken a cumulative dosage of 28,000 mg or more throughout the course of the study.
In another 2011 study done in the United States looked at the “Adverse Event” reports compiled by the FDA between 2004-2009, this study had similar results as their European counterpart and led the FDA to issue a warning stating Actos users faced a “disproportionate risk” of bladder cancer. There is also information to suggest that Actos is linked to live, prostate, and kidney cancer.
Actos was also always believed to be a safer alternative to its counterpart Avandia in relation to cardiovascular disease and heart attack; however recent data seems to point to the contrary. In a study analyzing about 29,000 patients from 2001-2005, factoring in age, gender, and prior heart disease, it was shown that about 4% of both Avandia and Actos users suffered a heart attack, heart failure, or died.
For these reasons the FDA has placed a “black box” warning on Actos, the highest warning given out by the FDA. The FDA has decided that the rewards outweigh the risks of Actos and therefore it remains on the market in the United States.
Following is a timeline of events associated with Actos Litigation:
Jul. 15, 1999: The U.S. Food and Drug Administration (FDA) approves Actos to treat patients diagnosed with type 2 diabetes. The drug is launched by manufacturers Takeda Pharmaceutical and Eli Lilly & Co.
Oct. 13, 2000: The European Medicines Agency (EMA) approves Actos to treat type 2 diabetes
2006-2009: In France, a government funded study collects data from diabetic patients taking Actos
Aug. 14, 2007: FDA releases an alert regarding Actos and other drugs in the same class, included is a new “boxed” warning on their labels. The agency says the alert is meant “to emphasize that pioglitazone may cause or exacerbate heart failure, particularly in certain patient populations.” The blackbox warning is addressed to large manufacturers Takeda and GlaxoSmithKline, the makers Avandia
Jan-Oct 2010: In United State pharmacies, around 2.3 million patients fill a prescription for Actos or medication containing Actos, according to the FDA
Sept. 17, 2010: The FDA conducts an ongoing safety review concerning the increased risk of bladder cancer associated with exposure to Actos. The FDA states that it is analyzing data from an ongoing ten-year study looking at the relationship between the drug and bladder cancer. Though some findings in animal and human studies suggest a possible connection, the FDA does not make any definitive statement about the link between Actos and bladder cancer.
Jun. 2010: A Whistleblower suit is filed against Takeda Pharmaceutical Co. Under the False Claims Act, former medical reviewer Helen Ge, files a suit on the government’s behalf alleging that cases of congestive heart failure “were not properly identified or reported in the FDA’s safety database,”
Jun. 9, 2011: The EMA issues a press release concerning findings from the French Medicines Agency, and the decision to suspend Actos from the market.
Jun 10, 2011: Use of Actos is banned in France and Germany. The French Medicines Agency removed the drug from the market after analyzing the data collected from 2006 to 2009.
Jun. 15, 2011: FDA announces “that use of the diabetes medication Actos (pioglitazone) for more than one year may be associated with an increased risk of bladder cancer.” Warning labels are to be updated subsequently. The agency warns healthcare professionals against prescribing Actos in patients who have bladder cancer or have a history of bladder cancer.
Jul. 2011: The EMA states that Actos should include the risk of bladder cancer on its warning label.
Dec. 2011: Takeda may face over 10,000 lawsuits, according Bloomberg Businessweek
At Sheff Law, we are the Massachusetts law firm with the resources, experience, and national reputation to investigate personal injuries and wrongful deaths resulting from taking Actos. Patients across Massachusetts and America are starting to realize some of the potential harmful consequences of using Actos. If you or a loved one has been injured as a result of Actos, contact an attorney at Sheff Law today by filling out a FREE consultation form, or call at (888) 423-4477 or 617-227-7000.
February 23rd, 2016 | Posted in Blog