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Actos Bladder Cancer Side Effects Lawsuits

Actos (Pioglitazone Hydrochloride) Actos Side Effects May Include; Bladder Cancer, Heart Attacks, Cardiovascular Heart Risks | FDA Warning: Diabetes Drug may Increase Bladder Cancer Risk | Actos Linked to Serious Health Issues

Actos Bladder Cancer, Side Effect Study

According to the website EHealthMe, a study conducted on August 17, 2011 regarding the side effects of taking Actos and bladder cancer risk. According to the report, 22,512 reported side effects when taking Actos and 0.22% have bladder cancer. The largest concentration (approx. 43%) were using Actos between 2-5 years before having Bladder Cancer with the next largest concentration (approx. 29%) used Actos between 1-6 months.

Actos Drugs

• ACTOPLUS MET (Active Ingrediant: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE)
• ACTOPLUS MET XR (Active Ingrediant: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE)
• ACTOS (Active Ingrediant: PIOGLITAZONE HYDROCHLORIDE)
• DUETACT (Active Ingrediant: GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE)
• PIOGLITAZONE (Active Ingrediant: PIOGLITAZONE HYDROCHLORIDE)
• PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE (Active Ingrediant: METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE)

Actos Side Effects, Bladder Cancer Risk

What Side Effects are Possible from Actos?

In June 2011, the Type 2 Diabetes drug Actos (piogliatazone) had its sales suspended by medical regulators in France and Germany because of a possible bladder cancer risk. The French and German decisions to ban the drug came after a study commissioned by the French Medicines Agency found that people taking Actos were more likely to develop bladder cancer, 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 about a 22 percent higher risk of bladder cancer in 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 a possible bladder cancer risk in September 2010. 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 at least two years or at the highest cumulative doses (>28,000 mg) did face a greater danger from bladder cancer.

In May 2011, another study, this time looking at Adverse Event reports to the FDA between 2004-2009, 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.

If you are type 2 diabetic that has taken Actos and been diagnosed with bladder cancer, the defective drug attorneys at Parker Waichman LLP are offering free lawsuit evaluations. Please complete our online form or contact us at 1-800-LAW-INFO (1-800-529-4636).

New Research May Indicate Actos Cardiovascular, Heart Disease Side Effects and Risks

Effect Of Actos On Cardiovascular Disease

New research has added to the growing body of evidence linking Avandia and Actos to increased adverse health risks. Avandia has long been surrounded with debate concerning cardiovascular risks, while Actos was believed a safer alternative, causing sales of Actos to increase and Avandia sales seeing significant declines. The LA Times has stated that emerging research suggests that similar heart risks are being seen in both drugs, said the LA Times, which explained that both are part of the class called thizolidinediones. Thizolidinediones reduce body tissue insulin resistance and adjust cholesterol levels and are considered some of the strongest medications for treatment of Type 2 diabetes, noted the LA Times.

A 2007 study with over 200,000 Medicare patients pointed to Avandia's (generic: rosiglitazone) increased heart attack risks, cardiovascular disease, stroke, and death by 30-to-40 percent,” versus other, older diabetes medications, said the LA Times. That study indicated that the risk was not seen with Actos (generic: pioglitazone), added the LA Times.

The study prompted stronger U.S. Food and Drug Administration (FDA) label warnings, with even stronger warnings following more reports of increased risks with Avandia, said the LA Times; an FDA panel found the benefits of Avandia outweighed its risks and that it should remain on the market, but that no more patients be enrolled in a prospective study comparing the two drugs directly.

The team, led by Debra Wertz an outcomes research manager at HealthCore Inc., a Wellpoint Inc. research subsidiary—analyzed 28,938 patient records for people who took either medication from 2001 to 2005, obtaining company data, said the LA Times. Death information was derived from the National Death Index, which is managed by the National Center for Health Statistics. The research appears in the journal Circulation: Cardiovascular Quality and Outcomes.

When accounting age, gender, and prior heart disease, about four percent per group either suffered a heart attack or heart failure or died, said the LA Times. The figures break down to 96 Avandia, versus 121 Actos patients suffering a heart attack and 265 Avandia and 243 Actos patients suffering from heart failure, said the LA Times; 217 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 the LA Times, and that the study followed younger patients longer than in prior studies. Earlier studies did not include stroke data, which could affect outcomes.

Another Study May Indicate Actos May Increase Risk Of Fractures

Many seniors may be at increased risk for fractures.

Parker Waichman LLP had written previously that another study linked Avandia and Actos to an increased risk of fractures. The research appeared in the Journal of Clinical Endocrinology & Metabolism and 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 percent likelier to have been prescribed a thiazolidinedione. In men, the increased risk (more than triple) was seen among those taking both a thiazolidinedione and loop diuretics, like Lasix, but not in just one or the other. The researchers pointed out that loop diuretics have been linked with bone density decreases. In both genders, the fracture risk went up 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 included in the study suffered lower limb, arm, and leg fractures.

FDA Requires Actos To Have A Black Box Warning

After an intense debate over the safety of the Type-2 Diabetes drug Actos, the FDA has stated that the heart risk warnings on Actos (pioglitazone) will now be surrounded by an emphatic black outline known as a black box warning due to 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.

Actos is a newer class of diabetes drugs called thiazolidinediones or glitazones, which increase the body's sensitivity to insulin. The FDA (Food and Drug Administration) approved Actos on July 15, 1999. Actos is manufactured by Takeda Chemical Industries.

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. Avandia is another drug that is a thiazolidinediones or glitazones.

The American Heart Association and American Diabetes Association issued recommendations to guide the use of Actos, a glucose-lowering drug and other drugs classified as thiazolidinediones (TZDs). Diabetics who have mild heart disease or any problems with their kidneys may be at an increased risk of developing congestive heart failure if they take certain diabetes medications, according to a new 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 years, with type 2 diabetes who had gone to the emergency room at 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 the diabetes medications for between one month and 16 months. Three people developed symptoms within one to three months after the dose of their diabetes drug had been increased.

Actos Side Effects Victims - Legal Help

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 or call us at 1-800-LAW-INFO (1-800-529-4636).

Actos Timeline

Jul. 15, 1999: The U.S. Food and Drug Administration (FDA) approves Actos to treat patients diagnosed with type 2 diabetes mellitus. 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 mellitus

2006-2009: As part of a government funded study, data is collected from diabetic patients taking Actos in France

Aug. 14, 2007: FDA releases a safety alert concerning Actos and other similar drugs, to include a new “boxed” warning on their labels. The agency stated that the alert was meant “to emphasize that pioglitazone may cause or exacerbate heart failure, particularly in certain patient populations.” The blackbox warning was addressed to Takeda and GlaxoSmithKline, who manufactures Avandia

Apr. 2009: Takeda buys back the rights to Actos from Eli Lilly in seven countries including Canada, Sweden and Norway. In explaining the motive behind this strategic move, Takeda said it was an effort to increase “the enhancement of our presence in each region of the world to further establish Takeda as a world-class pharmaceutical company.” cites FiercePharma

Jan-Oct 2010: At outpatient retail pharmacies, an estimated 2.3 million patients fill a prescription for Actos or medication containing Actos, according to the FDA

Sept. 17, 2010: The FDA is conducting an ongoing safety review concerning the increased risk of bladder cancer associated with exposure to Actos. The agency states that it is analyzing data from an ongoing ten-year study looking at the relationship between the drug and bladder cancer. Although 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,”

Mar. 16, 2011: By request of the European Commission, the EMA’s Committee for Medicinal Products for Human Use CHMP starts a review of Actos, Glustin, Competact, Glubraca and Tandemact to analyze the use of these medications related to the risk of bladder cancer.

Jun. 9, 2011: The EMA issues a press release concerning findings from the French Medicines Agency, and its decision to suspend Actos from the market. The EMA does not make any definitive claims at this point, but states that ongoing reviews will continue.

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, according to Reuters.

Dec. 2011: Takeda may face over 10,000 lawsuits, according Bloomberg Businessweek

Mar 12, 2012: Jerrold Parker, co-founder of Parker Waichman LLP, is named to the Plantiffs’ Steering Committee, in the multidistrict litigation (MDL) No. 2299.

References:
http://www.bloomberg.com/news/2012-03-07/takeda-hid-actos-linked-heart-failure-cases-whistle-blower-claims-in-suit.html
http://www.taf.org/whyfca.htm
http://www.fda.gov/Drugs/DrugSafety/ucm259150.htm
http://www.fda.gov/drugs/drugsafety/postmarketdrugsafetyinformationforpatientsandproviders/ucm109136.htm
http://www.fiercepharma.com/story/takeda-buys-back-lillys-actos-rights/2009-04-09
http://www.ema.europa.eu/ema/index.jsp?curl=pages/medicines/human/medicines/000285/human_med_000624.jsp&mid=WC0b01ac058001d124

Latest Actos News

September 6, 2011: Parker Waichman LLP files Lawsuit against makers of Diabetes drug Actos alleging Bladder Cancer Link

U.S. Food & Drug Administration (FDA) announces that use of Actos may increase risk of bladder cancer.