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Diabetes Drug Actos and the Risk of Bladder Cancer and Other Side Effects
The U.S. Food and Drug Administration (FDA) approved Actos, which is manufactured by Takeda Chemical Industries, on July 15, 1999. It includes the active ingredient pioglitazone hydrochloride, is used for treatment of type 2 and type 1 diabetes; type 1 diabetes mellitus; diabetes mellitus inadequate control; and high blood pressure.
- ActoPlus Met (active ingredient: metformin hydrochloride; pioglitazone hydrochloride)
- ActoPlus Met XR (active ingredient: metformin hydrochloride; pioglitazone hydrochloride)
- Actos (active ingredient: pioglitazone hydrochloride)
- DueTact (active ingredient: glimepiride; pioglitazone hydrochloride)
- Pioglitazone (active ingredient: pioglitazone hydrochloride)
- Pioglitazone hydrochloride and metformin hydrochloride (active ingredient: metformin hydrochloride; pioglitazone hydrochloride)
First Actos Bladder Cancer Bellwether Trial in Progress
The first Actos bellwether trial continues to progress with jury selection having been completed. The couple who brought the case being represented in this first bellwether allege that the husband was prescribed and took Actos to treat his Type 2 diabetes from 2004 to 2011; in 2011, he was diagnosed with bladder cancer. He alleges that it was his taking Actos that caused him to develop cancer and that Takeda Pharmaceutical Co., the maker of Actos, hid the drug’s potential risks from the public.
This couple’s claim’s are similar to the claims that have been made in the 2,700 other lawsuits that are pending in the Actos multidistrict litigation (MDL). Actos patients who have brought lawsuits all generally allege that Takeda ignored or minimized Actos’ association with increased cancer risks prior to the drug being released in the United States in 1999. Litigation also includes arguments that Takeda misled U.S. regulators about these risks. This bellwether is expected help determine how the remaining cases will proceed.
Studies, Data Regarding Actos-Bladder Cancer Link
The website eHealthMe conducted a study on May 24, 2013 to analyze Actos and the risk of bladder cancer. In total 29,989 Actos users participated in the study, which is also based on reports from the U.S. Food and Drug Administration (FDA) and is updated regularly.
In the latest analysis: 29,989 people reported having side effects while taking Actos. Among them, 1,631 people (or 5.44%) developed bladder cancer. The largest concentration (about 39.48%) were using Actos between two and five years before developing bladder cancer, with the next-largest concentration (about 32.17%) using Actos between five and 10 years.
In June 2011, medical regulators in France and Germany suspended sales of the type 2 diabetes drug Actos (pioglitazone) because of a possible link to bladder cancer. The French and German decisions to ban the drug followed a study commissioned by the French Medicines Agency which found that people taking Actos were more likely to develop bladder cancer, which is an aggressive form of cancer. The study examined cancer rates in some 155,000 people taking Actos in France from 2006 to 2009, and 1.3 million other diabetics who were not receiving the drug. The study found that the risk of bladder cancer was about 22% higher among those taking the drug compared with diabetics taking other drugs. The bladder cancer risk was highest in those receiving a cumulative dosage of 28,000 mg or more during the study period.
Also in June 2011, the U.S. Food & Drug Administration (FDA) announced it was reviewing Actos for possible bladder cancer risk based on a September 2010 safety review. At the time the agency said early data from a 10-year study submitted by Takeda, the maker of Actos, had not indicated a statistically significant association between exposure to the drug and bladder cancer risk. However, there was some evidence that patients taking Actos for at least two years or at the highest cumulative doses (>28,000 mg) did face a greater risk of bladder cancer.
In May 2011, another study, this one looking at adverse event reports sent to the FDA between 2004 and 2009, suggested that Actos patients faced a "disproportionate risk” of bladder cancer. The study looked at a half-million side effect reports associated with various diabetes medications and found that a fifth of those involving bladder cancer occurred in patients using the drug.
New Research May Indicate Actos Also Linked to Greater Risk of Cardiovascular, Heart Disease Side Effects and Risks
New research has been added to the growing body of evidence linking Avandia and Actos to increased adverse health risks. Avandia has long been the center of a debate concerning cardiovascular risks, while Actos has been considered a safer alternative; this has helped sales of Actos skyrocket above Avandia.
Both Actos and Avandia fall into the thizolidinedione class. Thizolidinediones reduce insulin resistance in body tissue as well as adjust cholesterol levels; the drug class is considered to include the strongest medications for treatment of type 2 diabetes, according to the Los Angeles Times.
The Los Angeles Times reported on a 2007 study in which more than 200,000 Medicare patients participated. The study noted that Avandia (rosiglitazone) users experienced an increased risk of heart attack, cardiovascular disease, stroke, and death by 30% to 40%, compared with older diabetes medications, according to the Los Angeles Times. The study indicated that the risk was not seen with Actos.
The study prompted strong FDA label warnings, with even stronger warnings following more reports of increased risks with Avandia, said the Los Angeles Times. An FDA panel found that Avandia’s benefits outweighed its risks and that it should remain on the market; the panel also said that no more patients were to be enrolled in prospective studies comparing the two drugs.
The panel, led by Debra Wertz, outcomes research manager at HealthCore Inc., a Wellpoint Inc. research subsidiary, analyzed the records of 28,938 patients who took either medication from 2001 to 2005, obtaining company data, said the Los Angeles Times. Death information was derived from the National Death Index, which is managed by the National Center for Health Statistics. The research appeared in the journal Circulation: Cardiovascular Quality and Outcomes.
Accounting for age, gender, and prior heart disease, about 4% of each group either suffered a heart attack or heart failure or died, said the Los Angeles Times. The figures break down to 96 Avandia patients and 121 Actos patients suffering heart attacks, and 265 Avandia patients and 243 Actos patients suffering from heart failure, said the Los Angeles Times; 217 patients in each group died.
"What distinguishes this latest study from other claims-based analyses is its analysis of death records, which include out-of-hospital deaths," Wertz said in a statement quoted by the Los Angeles Times. Also, the study followed younger patients longer than did previous studies. Earlier studies also did not include stroke data, which could affect outcomes.
One Study Indicates Actos May Increase Risk of Fractures
Another study linked Avandia and Actos to an increased risk of fractures. The research, which appeared in the Journal of Clinical Endocrinology & Metabolism, found that the drugs increased the risk of fractures in postmenopausal women with type 2 diabetes, as well as in men prescribed either drug with a loop diuretic.
Women over 50 who had broken bones were 71% likelier to have been prescribed a thiazolidinedione. In men, this risk more than tripled and was seen among those taking both a thiazolidinedione and loop diuretic, like Lasix, but not in just one or the other. The researchers pointed out that loop diuretics have been linked to bone density decreases. In both genders, the fracture risk increased the longer a person was on the medication. According to the researchers, the fractures seen in the study were not just the spine and hip fractures most often seen in people with osteoporosis. Many of the people in the study suffered lower-limb arm and leg fractures.
FDA Requires Actos to Include a Black Box Warning
After an intense debate over the safety of the type 2 diabetes drug Actos, the FDA stated that a black box warning must be added to the heart risk warnings on Actos (pioglitazone), due to the serious risk of adverse cardiovascular events, including heart attack, heart failure, and cardiovascular-related deaths. The black box warning is the strongest FDA-requested label change that can be added to a drug.
The first approved drug in the class, Rezulin, was taken off the market in 2000 after it was linked to dozens of cases of fatal liver disease.
The American Heart Association and American Diabetes Association both issued recommendations to guide Actos use, a glucose-lowering drug, and other drugs classified as thiazolidinediones (TZDs). Diabetics with mild heart disease or any kidney problems may be at an increased risk of developing congestive heart failure if they take certain diabetes medications, according to a study.
The study, published in the September 9, 2003 issue of the Mayo Clinic Proceedings, reported on six cases of congestive heart failure in people taking pioglitazone (Actos) or rosiglitazone (Avandia) to help control their diabetes. The researchers studied the records of six men between the ages of 66 and 78 with type 2 diabetes who had gone to the Dallas Veterans Affairs Medical Center emergency room.
All six patients complained of shortness of breath, swelling of their feet, and weight gain, which are symptoms of congestive heart failure and pulmonary edema (fluid buildup in the lungs). Congestive heart failure occurs when the heart can no longer pump enough blood to maintain adequate circulation. Because the heart doesn't pump properly, fluid often builds up in the lungs.
Four of the six people in this study had chronic renal insufficiency, which means that their kidneys weren't functioning normally. Only two had any previous signs of heart disease. Four of the six had high blood pressure. They had been on diabetes medications for between one and 16 months. Three people developed symptoms within one to three months, when their diabetes drug dosage had been increased.
In 2002, Takeda was criticized over some promotional material designed to promote Actos. The company received a letter from the Department of Health & Human Services’ Division of Drug Marketing, Advertising and Communications (DDMAC). It said that after reviewing promotional materials designed to support Actos, it had determined that the material, which was distributed at an industry trade show in 2002, violated the Federal Food, Drug and Cosmetic Act. Specifically, the material was misleading in that it omitted important safety information and also highlighted results that have not been demonstrated, the regulator said.
Legal Help for Actos Side Effects Victims
If you or a loved one took Actos and suffered bladder cancer, or other side effects, please fill out the form on the right for a free case evaluation by a qualified defective drug side effects attorney.